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Philips Respironics, Inc. Recall 87753

Description: BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177

Philips Respironics, Inc. Recall 87753 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1627-2021
Event ID87753
Event DescriptionBiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
Product TypeDevices
DistributionDistribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan
Quantity1 unit
Recall ReasonCertain 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.
Device Classification20210602
Device Code InfoSerial Number: V30562261B40E
Center Classification Date20210521
Recall Initiation Date20210406
Recalling FirmPhilips Respironics, Inc.
Initial Notification Letter
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