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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

Philips Respironics, Inc. 2023-10-04 Health critical FDA
Health · FDA · Recall #FDA-Z-2631-2023

Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60… Recall

Issued October 4, 2023 · Philips Respironics, Inc.

In October 2023, Philips Respironics, Inc. recalled the Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.

What you should do

  1. 1 Stop using Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Philips Respironics, Inc. to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Philips Respironics, Inc.
Category
Health
Recall date
October 4, 2023
Units affected
Not reported
Sold at
US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
Recall number
FDA-Z-2631-2023
Made in
United States
Issuing agency
FDA

In context

  • Philips Respironics, Inc. has 7 recalls in our database, including 7 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 903rd Health recall we've logged in 2023.
Read the official FDA notice

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