Philips Respironics V60 Ventilator Recalled for Potential Backup Battery Failures
Respironics is recalling 216 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 involves a critical life-support device (ventilator) where a battery failure could result in a lack of ventilation. Although no specific injuries or illnesses are reported in the source text, the potential for serious harm from a device failure in a medical context aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Respironics California, LLC is recalling 216 units of the Philips Respironics V60 Ventilator (Part Number 1076717). The recall is due to potential issues with the backup battery. The battery may fail if it 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 units were distributed worldwide, including nationwide in the United States and in numerous countries across multiple continents. The ventilators are intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Consumers and healthcare facilities should check their V60 Ventilator serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a unit is affected, users should follow the instructions provided by Respironics regarding the backup battery.
The recalled product
- Product
- Philips Respironics V60 Ventilator Part Number 1076717 - 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
- 216
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 1076717 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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