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U.S. Department of Health and Human Services

Class 1 Device Recall Philips Respironics V60/V60 Plus Ventilator

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  Class 1 Device Recall Philips Respironics V60/V60 Plus Ventilator see related information
Date Initiated by Firm August 25, 2023
Date Posted September 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-2631-2023
Recall Event ID 93015
510(K)Number K102985  
Product Classification Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
Product Philips Respironics V60/V60 Plus Ventilator,

PCBA Part Number: 453561544461

V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Code Information V60 Device Serial # /PCBA Serial # 201019564 SC23120K8 201014394 SC23120NH 201017048 SC2312133 100246411 SC231116C 100246416 SC231117H 100085632 SC2311127 100013579 SC23110EV 100082334 SC2311138 ***Updated November 6, 2023*** 100423818 SC2311168 100293267 SC2312154 100006900 SC2311165 100006889 SC23110MF 201010175 SC231104X (Philippines)
Recalling Firm/
Manufacturer		 Philips Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
For Additional Information Contact Philips Customer Service
800-722-9377
Manufacturer Reason
for Recall		 Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Impacted customers were contacted via phone and email on August 25, 2023. Philips released an "Urgent Medical Device Correction" customer letter to make customers aware of the potential for a power failure leading to ventilator loss of function. Instructions to Customer Discontinue use of and quarantine these device(s) until you are contacted by a Philips Respironics representative to remove and/or replace the Power Management PCBAs in the affected device(s). Philips Respironics will contact you to coordinate a time to remove and/or replace the impacted component located within your device(s). If you need any further information or support with this issue, please contact your local Philips Respironics representative, or call the Philips Respironics Customer Care Solutions Center at 1 (800) 722-9377. ***Updated November 2023*** Customers of the additional impacted PCBAs were contacted via phone and email on November 3, 2023.
Quantity in Commerce 9 (8 US; 1 OUS)
Distribution US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MNT and Original Applicant = Respironics Inc.
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