Reported May 29, 2024 · Ongoing
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149…
Philips Respironics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Respironics, Inc. · 1001 Murry Ridge Ln · Murrysville, PA · 15668-8517
Is this the product you have?
- BiPAP A30 Ventilator, Part
- Number 1111143 (US and OUS) OUS OnlyPart Numbers
1111144111114511111471111148111114911111501111154111118111161551111144L1111144M1111144VBR1111143CN1111143R1111143R1111150R1111181
- Lot codes and dates
- US distributionMaterial No. 1111143 UDI-DI 00606959039308 Serial Numbers N182942836566 N14644718E852
- N16489657EE4B -- OUS distributionMaterial No. 1111143 UDI-DI 606959067493 Serial Nos.
2,315 of 2,315 codes
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
- Amount recalled
- 3 US; 21,414 OUS
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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