Reported May 29, 2024 · Ongoing
BiPAP A40 Ventilators
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 A40 Ventilators
3 of 3 products
| # | Product as published |
|---|---|
| 1 | BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 |
| 2 | BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H19 INX3100S19 ITX3100S21 SPX3100S19 |
| 3 | BiPAP A40 EFL, Part Numbers (OUS Only): AUX3000S19 DEX2900S13 DEX3000S13 EEX3000S19 ESX3000S19 FRX3000S14 GBX3000S19 INX3000H19 ITX3000S21 |
- Lot codes and dates
- USMaterial No. 1111169 UDI-DI 00606959039476 Serial Numbers V182393118CC9 V21942863DD70 V219429359C22 V25585948745C
- V26439189762A V2640770372E7 OUSA40: Material No. 1111169 UDI-DI 00606959039476 Serial Numbers
2,313 of 2,313 codes
V09765327781AV09765332366FV097653405875V097653436AEEV097653472CCAV0976535041ADV097653551600V09765356249BV09765358CDE5V100863961519V10086398FC67V10086399EDEEV100864020820V10086408A77AV1008641032EAV100864112363V100864130071V1008641474CEV100864201882V100864223B90V100864276C3DV10086436646CV100864388D12V100864399C9BV100864426F40V100864437EC9V100864462964V10086448C01AV10086450558AV100864514403V100864527698V100864536711V100864550227V1008645630BCV10086459C84BV100864616E6BV100864634D79V1008646439C6V10086465284FV100864670B5DV10086468F3AAV1008643333C1V1008647177B3V100864724528V100864771285V10086478EA72V10086479FBFBV1008648869BAV100864013ABBV100864267DB4V100864451BFFV10086458D9C2V100864625CF0V100864753197V10086484A3D6V10086476030CV10086509EC2FV100865489AC6V10086482C6E0V1008643556F7
- Amount recalled
- 6 US, 60,417 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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