Recall Z-1630-2021 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Philips Respironics, Inc.
BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
| Date | Apr 6, 2021 |
| Status | Terminated |
| Reason | Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider. |
| Root cause | Nonconforming Material/Component |
| Action | In April, 2021, Philips issued an Urgent Medical Device Removal notice to customers via letter notifying them that Philips determined that certain devices were built with motor assemblies that could contain non-conforming plastic material. ACTION TO BE TAKEN BY CUSTOMER / USER 1. Locate all impacted devices listed above immediately STOP USE. All impacted devices must be removed from service. Replace with a non-impacted device if it is being used by a patient. 2. This notice needs to be passed on to all those who must be aware within your organization or to any organization where the impact |
| Quantity | 4 units |
| Distribution | Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.