Philips Respironics V60 Plus Ventilators with Defective Adhesive Recalled
Respironics California is recalling 294 V60 Plus ventilators assembled with expired adhesive. The adhesive may fail, causing the bracket to loosen and damage capacitors, potentially stopping ventilation delivery.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity of 4 per the classification guidelines. Although no illnesses or injuries have been reported, the defect creates risk of complete loss of ventilation in a critical life-support device.
Plain-English summary
Respironics California is recalling 294 Philips Respironics V60 Plus ventilator systems (Model V60, Part Number 1138747). These units were assembled with expired adhesive on the capacitor motor driver PCB bracket component.
The expired adhesive may fail, causing the bracket to become loose. A loose bracket can damage the capacitors, potentially resulting in the ventilator stopping ventilation delivery to the patient. This failure could occur either with or without alarm notification.
The recalled systems were distributed across the United States, including Arkansas, California, Florida, Georgia, Indiana, Louisiana, Maryland, Missouri, New York, Pennsylvania, South Carolina, Tennessee, and Texas.
The potential for a ventilator to suddenly stop ventilation without notice represents a serious safety concern for patients dependent on these devices for respiratory support.
The recalled product
- Product
- Philips Respironics V60 Plus Ventilator Part Number 1138747
- Manufacturer
- Respironics California, LLC
- Affected units
- 294
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
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
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- Severe
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