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U.S. Department of Health and Human Services

Class 2 Device Recall BiPAP A40, Brazil

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 Class 2 Device Recall BiPAP A40, Brazilsee related information
Date Initiated by FirmApril 06, 2021
Create DateMay 21, 2021
Recall Status1 Terminated 3 on January 17, 2024
Recall NumberZ-1630-2021
Recall Event ID 87753
Product Classification Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
ProductBiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
Code Information Serial Number: V306120599B37, V3061207124CF, V30612105753F, V306121267414 
Recalling Firm/
Manufacturer		 Philips Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
For Additional Information ContactAdam Price
724-733-0200
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionIn April, 2021, Philips issued an Urgent Medical Device Removal notice to customers via letter notifying them that Philips determined that certain devices were built with motor assemblies that could contain non-conforming plastic material. ACTION TO BE TAKEN BY CUSTOMER / USER 1. Locate all impacted devices listed above immediately STOP USE. All impacted devices must be removed from service. Replace with a non-impacted device if it is being used by a patient. 2. This notice needs to be passed on to all those who must be aware within your organization or to any organization where the impacted devices have been transferred. 3. Once impacted devices have been removed from service and isolated notify your Philips Representative that the impacted devices are ready for return. Your Philips Representative will arrange for return of the device. Replacements will be provided free of charge. 4. Fill out the Business Reply Form that has been provided with this letter and return it to your Philips Representative. This form serves as official acknowledgement that you have fully performed your obligations to complete this medical device recall.
Quantity in Commerce4 units
DistributionDistribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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