Recall Z-1817-2024 ยท MNS Ventilator, Continuous, Non-Life-Supporting
Philips Respironics, Inc.
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
| Date | May 23, 2024 (initiated Apr 1, 2024) |
| Status | Open, Classified |
| Reason | Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death. |
| Root cause | Device Design |
| Action | Firm notified customers through mailed letter "URGENT Medical Device Recall" on April 1, 2024. The letter described the product, problem and actions to be taken. The firm reminded customers to refer to the user manual and to perform a clinical assessment prior to placing a patient on the ventilator to ensure that: 1. The device is appropriately set for patient requirements. 2. Alternate ventilation equipment is available. 3. Alternative monitoring is used where appropriate. Depending on the level of ventilatory support required, customers were advised to place patients on an alternate sour |
| Quantity | 9,388 US; 2,664 ROW |
| Distribution | US Nationwide distribution and OUS International distribution to Canada. |
| FDA record | Open on fda.gov |