Recall Z-1957-2021 ยท MNS Ventilator, Continuous, Non-Life-Supporting
Philips Respironics, Inc.
A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
| Date | Jul 15, 2021 (initiated Jun 14, 2021) |
| Status | Open, Classified |
| Reason | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. |
| Root cause | Device Design |
| Action | Urgent Medical Device Recall letters were sent to customers starting 6/14/21. 1. Do not stop or alter your prescribed therapy until you have talked to your physician. Your physician may evaluate if the benefit outweighs the risks. 2. If your physician determines that you must continue using this device, use an inline bacterial filter. Your Instructions for Use has guidance on installation. 3. Register your device on www.philips.com/src-update or call 1-877-907-7508. An updated URGENT: Medical Device Recall notification letter was issued on 11/16/21. 1. Do not stop or change ventilator use |
| Quantity | 8047 |
| Distribution | Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113053 | BIPAP A 30 VENTILATORY SUPPORT SYSTEM Respironics, Inc., Feb 1, 2012 |