Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk
Respironics is recalling 330 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.
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, and the hazard involves a life-support medical device (ventilator) where battery failure could lead to harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Respironics California, LLC is recalling 330 units of the Philips Respironics V60 Ventilator (Part Number 1053616). The recall is due to potential issues with the backup battery, which may fail 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 affected devices were distributed worldwide, including nationwide distribution in the United States and territories, as well as in numerous countries across Asia, Europe, Africa, the Americas, and Oceania. The source text does not specify the exact number of affected units in the U.S. versus international markets, nor does it list specific serial numbers in the narrative, though a list of serial numbers is provided in the structured data.
Consumers and healthcare facilities should check their V60 Ventilator serial numbers against the list provided in the official recall notice. If a device is affected, users should contact Respironics for instructions on how to proceed, which may include replacing the battery or the unit. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Philips Respironics V60 Ventilator Part Number 1053616 - 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
- 330
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 Ventilator
- Part Number 1053616 V60 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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