OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR
FDA device recall Z-1817-2024 · posted 2024-05-23 · Open, Classified
Recall details
- Recalling firm
- Philips Respironics, Inc.
- Reason for recall
- 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.
- Action taken
- 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 source of ventilation. Philips is currently investigating the issue. If you need any further information or support concerning this issue, please contact your local Philips Respironics representative: 1-800-345-6443, prompts 4, 5 or email at respironics.clinical@philips.com. A second "URGENT Medical Device Recall" notice was distributed to customers on June 12, 2024. In the notice customers were provided additional guidance on how to operate the device when a Ventilator Inoperative Alarm occurs and how to perform an optional hard reboot of their device that will temporarily restore functionality. An UPDATE URGENT Medical Device Recall Notice was mailed to consignees on 5/20/25 providing instructions on how to perform a Hard Reboot in the instance of a Ventilator Inoperable Alarm condition. Consignees are instructed to have users of the device review the OLA+ User Manual and the provided Appendix A.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- MNS
- Quantity affected
- 9,388 US; 2,664 ROW
- Distribution
- US Nationwide distribution and OUS International distribution to Canada.
- Date initiated
- 2024-04-01
- Date posted
- 2024-05-23
- Location
- Murrysville, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIPAP A 40 VENTILATORY SUPPORT SYSTEM (K121623) | Respironics, Inc. | 2012-12-14 |
| REMSTAR AUTO A-FLEX HT (K113068) | Respironics, Inc. | 2011-12-16 |
| BIPAP AUTOSV ADVANCED (K090539) | Respironics Inc., Sleep & Home Respiratory Group | 2009-10-30 |