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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

Philips Respironics, Inc.: V60 and V60 Plus Ventilators Recalled for Power Management Component Failure

Agency Publication Date: September 28, 2023
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Summary

Philips Respironics is recalling 15 V60 and V60 Plus Ventilators because the internal Power Management Printed Circuit Board Assemblies (PCBAs) may malfunction. This defect can lead to a sudden power failure and a complete loss of ventilator function, which is critical for patients requiring respiratory support. The recall affects 14 units in the United States and one in the Philippines. Consumers should contact their healthcare provider or the manufacturer immediately for guidance on these specific devices.

Risk

A malfunction in the power management circuit board can cause the ventilator to stop working entirely without warning. If the device fails, a patient may not receive necessary oxygen or breathing assistance, which could lead to serious adverse health consequences or death.

What You Should Do

  1. Locate the device serial number and the PCBA serial number on your Philips Respironics V60 or V60 Plus Ventilator.
  2. Check if your device matches one of the following affected V60 Serial Numbers: 201019564, 201014394, 201017048, 100246411, 100246416, 100085632, 100013579, 100082334, 100423818, 100293267, 100006900, 100006889, 201010175, 100385387, or 201029990.
  3. Verify the internal PCBA Serial Number against this list: SC23120K8, SC23120NH, SC2312133, SC231116C, SC231117H, SC2311127, SC23110EV, SC2311138, SC2311168, SC2312154, SC2311165, SC23110MF, SC231104X, SC231108T, or SC2311055.
  4. If your device is identified as affected, contact your healthcare provider or Philips Respironics immediately for further instructions regarding a potential repair or replacement.
  5. Contact Philips Respironics directly at their Murrysville, Pennsylvania location (1001 Murry Ridge Ln, Murrysville, PA 15668-8517) for technical support and corrective action details.
  6. For additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Philips Respironics V60 Ventilator
Model / REF:
1053617 (US)
1137276 (Philippines)
PCBA Part Number: 453561544461
Lot Numbers:
Device SN: 201019564 / PCBA SN: SC23120K8
Device SN: 201014394 / PCBA SN: SC23120NH
Device SN: 201017048 / PCBA SN: SC2312133
Device SN: 100246411 / PCBA SN: SC231116C
Device SN: 100246416 / PCBA SN: SC231117H
Device SN: 100085632 / PCBA SN: SC2311127
Device SN: 100013579 / PCBA SN: SC23110EV
Device SN: 100082334 / PCBA SN: SC2311138
Device SN: 100423818 / PCBA SN: SC2311168
Device SN: 100293267 / PCBA SN: SC2312154
Device SN: 100006900 / PCBA SN: SC2311165
Device SN: 100006889 / PCBA SN: SC23110MF
Device SN: 201010175 / PCBA SN: SC231104X
Device SN: 100385387 / PCBA SN: SC231108T
Device SN: 201029990 / PCBA SN: SC2311055
Product: Philips Respironics V60 Plus Ventilator
Model / REF:
PCBA Part Number: 453561544461

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93015
Status: Active
Manufacturer: Philips Respironics, Inc.
Sold By: Authorized Medical Distributors; Hospitals
Manufactured In: United States
Units Affected: 15 (14 US; 1 OUS)
Distributed To: Ohio, California, South Carolina, Oregon
Agency Last Updated: July 23, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.