Philips Respironics V60 Plus Ventilator Recalled for Battery Failure Risk
Respironics is recalling 702 V60 Plus Ventilators worldwide because the backup battery may fail if over-discharged or stored without AC power.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, a Class II recall without reported hospitalizations or injuries falls under 'High' severity, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Respironics California, LLC is recalling 702 units of the Philips Respironics V60 Plus Ventilator (Part Number 1138747) due to potential backup battery failures. The recall covers units distributed worldwide, including nationwide distribution in the United States and various international markets.
The hazard involves the backup battery potentially failing under two specific conditions: if the battery is allowed to over-discharge, or if the ventilator is stored for an extended period of time without being plugged into AC power. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Affected users should check their device serial numbers against the list provided in the official recall notice. The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
The recalled product
- Product
- Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
- Manufacturer
- Respironics California, LLC
- Category
- Medical Device — Ventilator
- Affected units
- 702
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)
- Model: V60 Plus Ventilator
- Part Number 1137276 V60 Plus Ventilator
Distribution
Part of a larger recall action
This product is one of 17 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 17 products in this recall →Related recalls
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