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Recall Observatory FDA recall evidence

Device product

BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178

Z-1625-2021

April 06, 2021

Class II

Product summary

Firm
Philips Respironics, Inc.
Event
Event 87753
Status
Terminated
Classification
Class II
Quantity
22 units
Official record key
device-enforcement:Z-1625-2021

Official wording

Reason: 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.

Code information: Serial Number: N3059246815B4, N305925228752, N30592449378D, N3059251913E9, N30592514C80C, N30592513BCB3, N30592515D985, N305924084164, N305925119FA1, N30592516EB1E, N305925180260, N30592457C72B, N306372301F1F, N306372551C62, N30637223345C, N30592416B1C2, N30592524E264, N30592520A440, N3059252396DB, N30592517FA97, N3059241492D0, N30592512AD3A.

Distribution pattern: Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.