{ "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": "43173", "product_res_number": "Z-0354-06", "event_date_initiated": "2005-11-18", "event_date_posted": "2006-01-06", "recall_status": "Terminated", "event_date_terminated": "2008-04-22", "res_event_number": "34129", "product_code": "CBK", "k_numbers": [ "K022750" ], "product_description": "The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PL V Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PL V Continuum is capable of providing the following types of ventilatory support:\n\n. Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece).\n. Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or Continuous Positive Airway Pressure (CP AP) modes of ventilation.\n. Volume-Controlled (VC). Available in AlC and SIMV.\n. Pressure-Controlled (PC). Available in AlC and SIMV.\n. Pressure Support (PS). Available in SIMV and SPONT.", "code_info": "Domestic Distribution Serial Numbers: VS4700581, VS4700661, VS4700631, VS4702578, VS4702507, VS4702551, VS4702583, VS4702589, VS4702590, VS470259], VS4702574, VS4702580, VS4702566, VS4700824, VS4702593, VS4700835, VS4700536, 1VS4700539, VS4700540, VS4700543, VS4700544, S4700546, VS4700548, VS4700549, VS4700550, VS4700552,VS4700554, VS4700555, VS4700558, VS4700565, VS4700566,VS4700567, VS4700569, VS4700573, VS4700574, VS4700577,VS4700578, VS4700580, VS4700581, VS4700585, VS4700588VS4700590, VS4700593, VS4700594, VS4700595, VS4700596, VS4700605, VS4700607, VS4700608, VS4700613, VS4700614, VS4700615, VS4700617, VS4700620, VS4700622, VS4700624, VS4700625, VS4700632, VS4700635, VS4700637, VS4700642, VS4700643, VS4700646, VS4700647, VS4700649, VS4700650, VS4700653, VS4700660, VS4700661, VS4700663, VS4700668, VS4700670, VS4700673, VS4700681, VS4700687, VS4700693, VS4700694, VS4700698, VS4700699, VS4700708, VS470071O, VS4700711, VS4700718, VS4700719, VS4700721, VS4700724, VS4700725, VS4700729, VS4700730, VS4700736, VS4700738, VS4700739, VS4700740, VS4700743, VS4700744, VS4700750, VS4700751, VS4700754, VS4700760, VS4700761, VS4700762, VS4700767, VS4700770, VS4700772, VS4700773, VS4700774, VS4700775, VS4700776, VS4700777, VS4700780, VS4700781, VS4700782, VS4700783, VS4700785, VS4700786, VS4700789, VS4700790, VS4700791, VS4700796, VS4700797, VS4700798, VS4700802, VS4700804, VS4700808, VS4700809, VS4700811, VS4700813, VS4700814, VS4700816, VS4700817, VS4700818, VS4700819, VS4700821, VS4700822, VS4700823, VS4700827, VS4700828, VS4700829, VS4700832, VS4700833, VS4700834, VS4700836, VS4700837, VS4700838, VS4700840, VS4700841, VS4700842, VS4700843, VS4700844, VS4700846, VS4700847, VS4700849, VS4700850, VS4700852, VS4700853, VS4700854, VS4700855, VS4700856, VS4702501, VS4702502, VS4702505, VS4702512, VS4702516, VS4702519, VS4702523, VS4702524, VS4702525, VS4702528, VS4702531, VS4702532, VS4702535, VS4702543, VS4702544, VS4702545, VS4702548, VS4702549, VS4702552, VS4702553, VS4702555, VS4702556, VS4702557, VS4702567, VS4702568, VS4702570, VS4702571, VS4702572, VS4702573, VS4702575, VS4702586, VS4702594, VS4702599, VS4702600, VS4702604, VS4702612, VS4702613, VS4702623, VS4702636, VS4702647, VS4702650, VS4702670, VS4702677, VS4702688, VS4702689, VS4702709, VS4702734, VS4702747, VS4702748, VS4702750, VS4702776, VS4702784, VS4702800, VS4702805, VS4702809, VS4702811, VS4702813, VS4702825, VS4702835, VS4702848, VS4702854, VS4702856, VS4702857, VS4702859, VS4702883, VS4702885, VS4702981, VS4703079, VS4703103  International Distribution Serial Numbers: VS4702605, VS4702608, VS4702609, VS4702631, VS4702632, VS4702634, VS4702642, VS4702643, VS4702659, VS4702719, VS4702754, VS4702759, VS4700792, VS4702722, VS4700563, VS4700696, VS4700820, VS4700601, VS4702645, VS4700839, VS4700644, VS4700589, VS4700703, VS4700723, VS4700746, VS4700553, VS4700628, VS4702962, VS4702983, VS4702995, VS4703006, VS4703023, VS4703041, VS4703056, VS4703064, VS4700717, VS4700645, VS4702915, VS4702500, VS4702828, VS4702858", "firm_fei_number": "2518422", "recalling_firm": "Respironics California Inc", "address_1": "2271 Cosmos Ct", "city": "Carlsbad", "state": "CA", "postal_code": "92009-1517", "additional_info_contact": "Anil Bhalani\n760-918-7458", "reason_for_recall": "During product testing of the PLV Continuum Ventilator's Safety Valve/Pressure Relief Valve (SV/PRV) at our manufacturing facility, Respironics found that when the PLY Continuum Ventilator is operated in the 'Face Up' orientation, the SV /PRV may stick in the open position, which may result in loss of delivered gas volume to the patient.", "root_cause_description": "Other", "action": "On November 18, 2005 all affected customers received a personal phone call from Respironics explaining the recall situation in detail. On November 21, 2005, an advisory notice was sent to customers via fax, email, or mail, instructing customers to only use your PLV Continuum Ventilator in the 'Face Foward' orientation. \n\nThe firm will contact customers with further information shortly to assure that this situation is positively resolved.\n\nCustomers were instructed to Only use the PL V Continuum Ventilator in the 'Face Forward' orientation.\n\nIn the event that a customer requires the application of the PLV Continuum Ventilator in the Face Up Orientation, Respironics will provide the customer, at no charge, with a rental PLV-l00, PLV-IO2b or PLV-I02 Ventilator for the customer to use until their PLV Continuum Ventilator is upgraded.\n\nIf additional information is needed the customer was instructed to contact Respironics'' Customer Service at 800 345-6443.", "product_quantity": "268", "distribution_pattern": "Nationwide, Taiwan, Saudi Arabia, Netherlands, Hong Kong, Canada, Brazil, Australia, and Argentina.", 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"3010017366", "3011213495", "2021710", "3008867836", "3009490946", "3038259592", "3006240053" ], "device_name": "Ventilator, Continuous, Facility Use", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5895", "device_class": "2" } } ] }