The Recall Desk
SevereFDA (Devices)·Z-0662-2022·Announced 2022-03-09

Philips V60 Ventilator Recall: Expired Adhesive May Cause Device Failure

A limited number of Philips Respironics V60 ventilators were assembled with expired adhesive. If the adhesive fails, the ventilator could stop providing ventilation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall. Although no illnesses or injuries have been reported, the hazard poses potential risk to a patient's ventilation, which is a critical life function. FDA Class I classification requires a minimum Severe severity rating.

Plain-English summary

A limited number of Philips Respironics V60 ventilators have been recalled. These systems were assembled with expired adhesive used in the mounting bracket assembly.

If the expired adhesive fails, the bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. The device could activate both visual and audible alarms when this occurs, or it could fail silently without any alarm notification.

The recall involves 16 ventilator systems that have been distributed across multiple U.S. states including Arkansas, California, Florida, Georgia, Indiana, Louisiana, Maryland, Missouri, New York, Pennsylvania, South Carolina, Tennessee, and Texas. Specific serial numbers have been identified by the FDA.

Healthcare providers who have received affected units should immediately discontinue use and contact the manufacturer for guidance on replacement or repair.

The recalled product

Product
Philips Respironics V60 Ventilator Part Number 1053617
Manufacturer
Respironics California, LLC
Category
Medical Device — Respiratory / Ventilator
Hazard
Affected units
16

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • The Component of the Ventilators that is impacted is: N 1034132 BRACKET
  • CAPACITOR

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 2 recalled by Respironics California, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Respironics California, LLC

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Same hazard · adhesive failure

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