Recall Z-1658-2022 ยท MNS Ventilator, Continuous, Non-Life-Supporting
Philips Respironics, Inc.
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
| Date | Sep 9, 2022 (initiated Aug 26, 2022) |
| Status | Open, Classified |
| Reason | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| Root cause | Process control |
| Action | The firm distributed an "URGENT Medical Device Recall" letter to customers dated 8/26/2022 via mail. The notification informs customers that certain BiPAP V30 Auto and OmniLab Advanced+ units distributed in the US have the potential to off-gas harmful chemicals and structural failure of the device motor due to nonconforming material used in the assembly. Patients are to stop using the recalled devices and consult with their physician to determine the most appropriate options for continued treatment. Customers are asked to locate all affected devices and immediately stop use and remove them f |
| Quantity | 34 units ***updated January 2024 *** additional 3 units |
| Distribution | Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY. Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, In |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090539 | BIPAP AUTOSV ADVANCED Respironics Inc., Sleep & Home Respiratory Group, Oct 30, 2009 |