{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "177038", "product_res_number": "Z-0756-2020", "event_date_initiated": "2019-09-27", "event_date_posted": "2020-01-10", "recall_status": "Terminated", "event_date_terminated": "2023-09-26", "res_event_number": "84034", "product_code": "CCK", "k_numbers": [ "K123195", "K150245", "K171028", "K183394" ], "product_description": "CARESCAPE Respiratory Module E-sCAiO", "code_info": "Mfg. Lot or Serial #\tUDI # SGV19240073HA\t010084068210418021SGV19240073HA11190611 SGV19280017HA\t010084068210418021SGV19280017HA11190708 SGV18150053HA\t010084068210418021SGV18150053HA11180411 SGV19240172HA\t010084068210418021SGV19240172HA11190612 SGV19240084HA\t010084068210418021SGV19240084HA11190611 SGV19240085HA\t010084068210418021SGV19240085HA11190611 SGV19240076HA\t010084068210418021SGV19240076HA11190611 SGV19240142HA\t010084068210418021SGV19240142HA11190612 SGV19280114HA\t010084068210418021SGV19280114HA11190709 SGV19280029HA\t010084068210418021SGV19280029HA11190708 SGV19240095HA\t010084068210418021SGV19240095HA11190611 SGV19270021HA\t010084068210418021SGV19270021HA11190702 SGV19240272HA\t010084068210418021SGV19240272HA11190613 SGV19270085HA\t010084068210418021SGV19270085HA11190704 SGV19260064HA\t010084068210418021SGV19260064HA11190628 SGV19240108HA\t010084068210418021SGV19240108HA11190611 SGV19240104HA\t010084068210418021SGV19240104HA11190611 SGV19240129HA\t010084068210418021SGV19240129HA11190612 SGV19240103HA\t010084068210418021SGV19240103HA11190611 SGV19240109HA\t010084068210418021SGV19240109HA11190611 SGV19250088HA\t010084068210418021SGV19250088HA11190617 SGV19250157HA\t010084068210418021SGV19250157HA11190620 SGV19250049HA\t010084068210418021SGV19250049HA11190617 SGV19240060HA\t010084068210418021SGV19240060HA11190611 SGV19240268HA\t010084068210418021SGV19240268HA11190613 SGV19250003HA\t010084068210418021SGV19250003HA11190617 SGV19250061HA\t010084068210418021SGV19250061HA11190617 SGV19250093HA\t010084068210418021SGV19250093HA11190617 SGV19250110HA\t010084068210418021SGV19250110HA11190620 SGV19250125HA\t010084068210418021SGV19250125HA11190620 SGV19260066HA\t010084068210418021SGV19260066HA11190628 SGV19260091HA\t010084068210418021SGV19260091HA11190628 SGV19250132HA\t010084068210418021SGV19250132HA11190620 SGV19260071HA\t010084068210418021SGV19260071HA11190628 SGV19250114HA\t010084068210418021SGV19250114HA11190620 SGV19290096HA\t010084068210418021SGV19290096HA11190716 SGV19250102HA\t010084068210418021SGV19250102HA11190620 SGV19280088HA\t010084068210418021SGV19280088HA11190708 SGV19270089HA\t010084068210418021SGV19270089HA11190704 SGV19240195HA\t010084068210418021SGV19240195HA11190612 SGV19260093HA\t010084068210418021SGV19260093HA11190628 SGV19300001HA\t010084068210418021SGV19300001HA11190723 SGV19280113HA\t010084068210418021SGV19280113HA11190709 SGV19240185HA\t010084068210418021SGV19240185HA11190612 SGV19270127HA\t010084068210418021SGV19270127HA11190705 SGV19250067HA\t010084068210418021SGV19250067HA11190617 SGV19270084HA\t010084068210418021SGV19270084HA11190704 SGV19280163HA\t010084068210418021SGV19280163HA11190709 SGV19280083HA\t010084068210418021SGV19280083HA11190708 SGV19270011HA\t010084068210418021SGV19270011HA11190702 SGV19260047HA\t010084068210418021SGV19260047HA11190628 SGV19280087HA\t010084068210418021SGV19280087HA11190708 SGV19240101HA\t010084068210418021SGV19240101HA11190611 SGV19240094HA\t010084068210418021SGV19240094HA11190611 SGV19240114HA\t010084068210418021SGV19240114HA11190611 SGV19240132HA\t010084068210418021SGV19240132HA11190612 SGV19240159HA\t010084068210418021SGV19240159HA11190612 SGV19240180HA\t010084068210418021SGV19240180HA11190612 SGV19240181HA\t010084068210418021SGV19240181HA11190612 SGV19240112HA\t010084068210418021SGV19240112HA11190611 SGV19240150HA\t010084068210418021SGV19240150HA11190612 SGV19240179HA\t010084068210418021SGV19240179HA11190612 SGV19240183HA\t010084068210418021SGV19240183HA11190612 SGV19240196HA\t010084068210418021SGV19240196HA11190612 SGV19240204HA\t010084068210418021SGV19240204HA11190612 SGV19240211HA\t010084068210418021SGV19240211HA11190612 SGV19270040HA\t010084068210418021SGV19270040HA11190702 SGV19280005HA\t010084068210418021SGV19280005HA11190708 SGV19280010HA\t010084068210418021SGV19280010HA11190708 SGV19240276HA\t010084068210418021SGV19240276HA11190613 SGV19270064HA\t010084068210418021SGV19270064HA11190704 SGV19270082HA\t010084068210418021SGV19270082HA11190704 SGV19270111HA\t010084068210418021SGV19270111HA11190705 SGV19280166HA\t010084068210418021SGV19280166HA11190709 SGV19260075HA\t010084068210418021SGV19260075HA11190628 SGV19260087HA\t010084068210418021SGV19260087HA11190628 SGV19260089HA\t010084068210418021SGV19260089HA11190628 SGV19250089HA\t010084068210418021SGV19250089HA11190617 SGV19240090HA\t010084068210418021SGV19240090HA11190611 SGV19240091HA\t010084068210418021SGV19240091HA11190611 SGV19240156HA\t010084068210418021SGV19240156HA11190612 SGV19240158HA\t010084068210418021SGV19240158HA11190612 SGV19240168HA\t010084068210418021SGV19240168HA11190612 SGV19240269HA\t010084068210418021SGV19240269HA11190613 SGV19240366HA\t010084068210418021SGV19240366HA11190613 SGV19240371HA\t010084068210418021SGV19240371HA11190613 SGV19240413HA\t010084068210418021SGV19240413HA11190613 SGV19250005HA\t010084068210418021SGV19250005HA11190617 SGV19250006HA\t010084068210418021SGV19250006HA11190617 SGV19250007HA\t010084068210418021SGV19250007HA11190617 SGV19250023HA\t010084068210418021SGV19250023HA11190617 SGV19250034HA\t010084068210418021SGV19250034HA11190617 SGV19250035HA\t010084068210418021SGV19250035HA11190617 SGV19250037HA\t010084068210418021SGV19250037HA11190617 SGV19250062HA\t010084068210418021SGV19250062HA11190617 SGV19250065HA\t010084068210418021SGV19250065HA11190617 SGV19250068HA\t010084068210418021SGV19250068HA11190617 SGV19250069HA\t010084068210418021SGV19250069HA11190617 SGV19250076HA\t010084068210418021SGV19250076HA11190617 SGV19250080HA\t010084068210418021SGV19250080HA11190617 SGV19250083HA\t010084068210418021SGV19250083HA11190617 SGV19250094HA\t010084068210418021SGV19250094HA11190617 SGV19250095HA\t010084068210418021SGV19250095HA11190617 SGV19250107HA\t010084068210418021SGV19250107HA11190620 SGV19250131HA\t010084068210418021SGV19250131HA11190620 SGV19250139HA\t010084068210418021SGV19250139HA11190620 SGV19260074HA\t010084068210418021SGV19260074HA11190628 SGV19260084HA\t010084068210418021SGV19260084HA11190628 SGV19250120HA\t010084068210418021SGV19250120HA11190620 SGV19290101HA\t010084068210418021SGV19290101HA11190716 SGV19290111HA\t010084068210418021SGV19290111HA11190716 SGV19290125HA\t010084068210418021SGV19290125HA11190718 SGV19290157HA\t010084068210418021SGV19290157HA11190718 SGV19260055HA\t010084068210418021SGV19260055HA11190628 SGV19260065HA\t010084068210418021SGV19260065HA11190628 SGV19260077HA\t010084068210418021SGV19260077HA11190628 SGV19270045HA\t010084068210418021SGV19270045HA11190702 SGV19300040HA\t010084068210418021SGV19300040HA11190723 SGV19300042HA\t010084068210418021SGV19300042HA11190723 SGV19280094HA\t010084068210418021SGV19280094HA11190709 SGV19290061HA\t010084068210418021SGV19290061HA11190715 SGV19290063HA\t010084068210418021SGV19290063HA11190715 SGV19250156HA\t010084068210418021SGV19250156HA11190620 SGV19280106HA\t010084068210418021SGV19280106HA11190709 SGV19280179HA\t010084068210418021SGV19280179HA11190709 SGV19280152HA\t010084068210418021SGV19280152HA11190709 SGV19280153HA\t010084068210418021SGV19280153HA11190709 SGV19280157HA\t010084068210418021SGV19280157HA11190709 SGV19260049HA\t010084068210418021SGV19260049HA11190628 SGV19260052HA\t010084068210418021SGV19260052HA11190628 SGV19260088HA\t010084068210418021SGV19260088HA11190628 SGV19270004HA\t010084068210418021SGV19270004HA11190702 SGV19270006HA\t010084068210418021SGV19270006HA11190702 SGV19270029HA\t010084068210418021SGV19270029HA11190702 SGV19270032HA\t010084068210418021SGV19270032HA11190702 SGV19270042HA\t010084068210418021SGV19270042HA11190702 SGV19270044HA\t010084068210418021SGV19270044HA11190702 SGV19270058HA\t010084068210418021SGV19270058HA11190704 SGV19270059HA\t010084068210418021SGV19270059HA11190704 SGV19270061HA\t010084068210418021SGV19270061HA11190704 SGV19270066HA\t010084068210418021SGV19270066HA11190704 SGV19270067HA\t010084068210418021SGV19270067HA11190704 SGV19270069HA\t010084068210418021SGV19270069HA11190704 SGV19270072HA\t010084068210418021SGV19270072HA11190704 SGV19270077HA\t010084068210418021SGV19270077HA11190704 SGV19270078HA\t010084068210418021SGV19270078HA11190704 SGV19280110HA\t010084068210418021SGV19280110HA11190709 SGV19280111HA\t010084068210418021SGV19280111HA11190709 SGV19280127HA\t010084068210418021SGV19280127HA11190709 SGV19280128HA\t010084068210418021SGV19280128HA11190709 SGV19280131HA\t010084068210418021SGV19280131HA11190709 SGV19280138HA\t010084068210418021SGV19280138HA11190709 SGV19280165HA\t010084068210418021SGV19280165HA11190709 SGV19280167HA\t010084068210418021SGV19280167HA11190709 SGV15101460HA\tNot Applicable SGV17350070HA\tNot Applicable SGV19269301HA\tNot Applicable SGV19269306HA\tNot Applicable SGV19269309HA\tNot Applicable SGV17060103HA\tNot Applicable SGV18300094HA\tNot Applicable", "firm_fei_number": "2126677", "recalling_firm": "GE Healthcare, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "GE Healthcare Service\n800-437-1171", "reason_for_recall": "Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.", "root_cause_description": "Process control", "action": "The firm issued the Urgent Medical Device Correction Letter dated 09/27/2019. The letter describes the failure and requests replacement of the affected module with another module. If a replacement is not available, the consignee is directed to follow the instructions below to ensure that your respiratory module O2 reading is within specifications (a) before any new patient case is started and (b) for prolonged patient cases, at a minimum of once a day: \n1) Connect the module to the host device;\n2) Ensure the module is fully warmed up by having it powered on for minimum 20 minutes;\n3) Configure the O2 reading and waveform to the host device screen as defined in the host device instructions;\n4) Feed 100% O2 gas flow from the ventilator to the module and observe the O2 reading and waveform; and\n5) Ensure the O2 reading is within specifications 100% +/-3% and there is no erratic behavior in the waveform.\n6) If you are unable to complete the above steps successfully, remove the respiratory module from clinical use and quarantine. \n\nContact GE Healthcare Service or your local Service Representative.\nIf you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "161 units", "distribution_pattern": "US\nOUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom", "openfda": { "k_number": [ "K883950", "K991086", "K182362", "K941165", "K874724", "K843599", "K001814", "K874754", "K221118", "K083056", "K023820", "K213911", "K850745", "K143127", "K990063", "K904789", "K192488", "K123690", "K230915", "K053204", "K014211", "K942849", "K133516", "K944052", "K131339", "K853396", "K910509", "K941982", "K083456", "K063167", "K171765", "K901861", "K920915", "K843285", "K770721", "K862605", "K973984", "K964305", "K983864", "K151421", "K851001", "K130112", "K905775", "K873959", "K142467", "K942567", "K930866", "K112368", "K920622", "K891076", "K930250", "K875268", "K161250", "K181981", "K950044", "K953006", "K093388", "K112840", "K140113", "K881206", "K121927", "K933980", "K002163", "K894691", "K911737", "K052582", "K864903", "K780324", "K971229", "K250148", "K072813", "K941971", "K052880", "K143150", "K944541", "K911193", "K963327", "K872760", "K980324", "K861398", "K921497", "K910019", "K831776", "K053174", "K851658", "K882748", "K171678", "K020046", "K133540", "K181624", "K884158", "K131506", "K192563", "K121017", "K881093", "K011536", "K172365", "K012391", "K890112", "K980979", "K122214", "K952325", "K870858", "K243956", "K261633", "K161860", "K925167", "K063813", "K883821", "K946044", "K132946", "K950387", "K921526", "K131410", "K150245", "K841498", "K896652", "K170820", "K894350", "K010795", "K852062", "K123043", "K210112", "K012139", "K900979", "K052167", "K911970", "K860556", "K800869", "K780107", "K862543", "K072220", "K923305", "K042601", "K894053", "K000712", "K983114", "K930559", "K802459", "K213767", "K993656", "K943977", "K110594", "K843970", "K770713", "K013845", "K914337", "K890874", "K992116", "K171828", "K895780", "K050066", "K031814", "K882172", "K140473", "K873856", "K984579", "K982969", "K842334", "K171028", "K173147", "K893589", "K904863", "K884080", "K981114", "K042665", "K211171", "K910106", "K903200", "K150272", "K890817", "K840966", "K072843", "K864199", "K962638", "K961150", "K041450", "K874036", "K251216", "K901132", "K133806", "K862880", "K942113", "K192446", "K980327", "K942772", "K930524", "K882661", "K831447", "K162343", "K896737", "K852463", "K212425", "K933284", "K954632", "K143469", "K030407", "K172904", "K120518", "K895001", "K190824", "K954120", "K810927", "K892406", "K925424", "K915494", "K871133", "K933707", "K900291", "K003982", "K040847", "K021576", "K925701", "K094012", "K812643", "K062115", "K951127", "K943389", "K093525", "K070128", "K792155", "K960972", "K935477", "K864902", "K954402", "K882885", "K171235", "K770968", "K980384", "K081601", "K103604", "K210019", "K183394", "K832005", "K040875", "K782138", "K833397", "K844010", "K896030", "K873149", "K770123", "K222511", "K970209", "K200594", "K973544", "K850746", "K920590", "K964239", "K850747", "K881002", "K041956", "K832767", "K823049", "K925484", "K863640", "K843844", "K011050", "K213518", "K913995", "K251641", "K023579", "K871828", "K203762", "K842325", "K873380", "K010024", "K220533", "K180902", "K924083", "K031741", "K122075", "K862559", "K915228", "K240937", "K964961", "K944400", "K791570", "K053063", "K980325", "K950581", "K100941", "K863703", "K253030", "K000520", "K181467", "K040011", "K873396", "K201590", "K051857", "K861213", "K842978", "K894429", "K982846", "K023454", "K012394", "K863883", "K031411", "K030886", "K871253", "K883090", "K950388", "K935272", "K080527", "K930957", "K012395", "K003550", "K833060" ], 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