Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US)
Summary
The FDA issued a Class I for Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 by Philips Respironics, Inc.. Reason: Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function..
Details
Source
Device Recall
External ID
Z-2631-2023
Action Date
2023-10-04
Status
Ongoing
Category
device
Product Description
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Lot/Code Info: 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) ***Updated July 23, 2024*** 100385387 SC231108T 201029990 SC2311055
Quantity Affected: 15 (14 US; 1 OUS)
Reason for Recall
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
Distribution
US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-25
Company
Murrysville, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 143 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Philips Respironics, Inc. has 74 FDA actions in our database, including 74 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Respironics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Respironics, Inc. have FDA actions?
Philips Respironics, Inc. has 74 FDA actions in our database, including 74 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2631-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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