{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "121932", "product_res_number": "Z-0012-2014", "event_date_initiated": "2013-08-30", "event_date_posted": "2013-10-17", "recall_status": "Terminated", "event_date_terminated": "2014-05-22", "res_event_number": "66277", "product_code": "JAA", "k_numbers": [ "K011624", "K081091", "K760466", "K801320", "K973039" ], "product_description": "GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. \n\nThis table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.", "code_info": "Serial # \t System ID 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Available\t0002872736 Not Available\t202745PRE Not Available\t203688P500 Not Available\t205286BRF Not Available\t214345PRF Not Available\t254562RF1 Not Available\t262OLCGOC1A Not Available\t270417RF1 Not Available\t407649LG2 Not Available\t414777MP2 Not Available\t504652RP2 Not Available\t573760PR1 Not Available\t580251ROOM1 Not Available\t601268W5 Not Available\t609835P500 Not Available\t610284PRO2 Not Available\t610284RF3 Not Available\t617726RF4E2 Not Available\t706754HR2 Not Available\t713770THUNDER Not Available\t717267RF6 Not Available\t815740XRDER Not Available\t909GERF1 Not Available\t912466P1207 Not Available\t928537RM1 Not Available\t956632RCR Not Available\t973972C308 Not Available\tDCOSDI000000011 Not Available\tDCOSDI000000018 Not Available\tDCOSDI000000222 Not Available\tDCOSDI000000703 Not Available\tDCOSDI00001717 Not Available\tDCOSDI00001740 Not Available\tDCOSDI00001752 Not Available\tDCOSDI100000008 Not Available\tDCOSDI100000043 Not Available\tDCOSDI100000152 Not Available\tDCOSDI100000272 Not Available\tDCOSDI100000412 Not Available\tDCOSDI100000700 Not Available\tDCOSDI100000820 Not Available\tDCOSDI110000289 Not Available\tDCOSDI140000071 Not Available\tDCOSDI200000107 Not Available\tDCOSDI200001358 Not Available\tDCOSDI300000408 Not Available\tDCOSDI300000436 Not Available\tDCOSDI300000440 Not Available\tDCOSDI300000920 Not Available\tDCOSDI400000063 Not Available\tDCOSDI400000167 Not Available\tDCOSDI50000419 Not Available\tDCOSDI50000425 Not Available\tDCOSDI50000426 Not Available\tDCOSDI600000212 Not Available\tKPICT Not Available\tLBDEMO2 Not Available\tRADNETRF1206 Not Available\tRADNETRF1213 Not Available\tRADNETRF1225 Not Available\tRADNETRF1240 Not Available\tRADNETRF1254 194130WK1\tRADNETRF186 Not Available\t416284LS16 Not Available\t506648L9A Not Available\t514934BRAD3", "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": "262-513-4122", "reason_for_recall": "GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle.\n\nThere is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON p", "root_cause_description": "Employee error", "action": "GE Healthcare sent an \"Urgent Medical Device Correction\" letter dated August 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\nCustomers were requested to inspect your power assist handle for either of the two conditions listed below. Immediately contact your local GE Healthcare Service Representative if any issue is found.\n\n1. If you observe that the power assist handle plastic grip is loose relative to\nthe mount, discontinue use.\n2. If plastic grip is secure, but you observe erratic performance, (power assist\nunresponsive, drifting of spotfilm device with no command, or lock release\nalways ON), you may continue to use the device with care. Use all safety\nprecautions relative to application of the myelographic stop and the inhibit,\ntable horizontal stop OFF.\n\nGE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction.\n\nIf you have any questions or concerns regarding this notification, please call one of the following phone numbers:\nUnited States: 800 437 1171\nJapan: 0120 055 919\nFor other countries, please contact your local GE Healthcare Service Representative\n\n.", "product_quantity": "810 (783 US, 27 OUS)", "distribution_pattern": "Worldwide Distribution - USA (nationwided) including DC., and the countries of AUSTRALIA, CANADA, CHILE, GERMANY, CHANA, GUATEMALA, ICELAND, ISRAEL, ITALY, JAMAICA, JAPAN, RUSIAN FEDERATION, UNITED ARAB EMIRATES and UNITED KINGDOM.", "openfda": { "k_number": [ "K840134", "K890745", "K922013", "K923453", "K081091", "K973073", "K913012", "K151485", "K801948", "K933472", "K970608", "K191713", "K992603", "K812963", "K111292", "K961193", "K884028", "K893644", "K973744", "K902982", "K944973", "K912341", "K024012", "K840364", "K930885", "K022911", "K993896", "K982028", "K813217", 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