OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
Reported: May 29, 2024 Initiated: April 1, 2024 #Z-1817-2024
Product Description
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
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.
Details
- Recalling Firm
- Philips Respironics, Inc.
- Units Affected
- 9,388 US; 2,664 ROW
- Distribution
- US Nationwide distribution and OUS International distribution to Canada.
- Location
- Murrysville, PA
Frequently Asked Questions
What product was recalled? ▼
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124. Recalled by Philips Respironics, Inc.. Units affected: 9,388 US; 2,664 ROW.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2024. Severity: Critical. Recall number: Z-1817-2024.
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