Reported Jun 2, 2021 · Terminated
BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
Philips Respironics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 V30 Auto
- US marketContinuous ventilator, non-life-supporting
- Material Number1111178
- Lot codes and dates
- Serial Number
N3059246815B4N305925228752N30592449378DN3059251913E9N30592514C80CN30592513BCB3N30592515D985N305924084164N305925119FA1N30592516EB1EN305925180260N30592457C72BN306372301F1FN306372551C62N30637223345CN30592416B1C2N30592524E264N30592520A440N3059252396DBN30592517FA97N3059241492D0N30592512AD3A
- Serial Number
- Amount recalled
- 22 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
This product could cause temporary or reversible health problems — stop using it.
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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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