Respironics V60 Ventilator Recalled for Power Management Board Software Issue
Respironics is recalling V60 ventilators due to a software issue on the Power Management Board Assembly that could cause loss of ventilator support without an audible alarm.
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: The recall involves a life-support medical device where a failure could result in the loss of ventilator support without an audible alarm, representing a significant injury risk consistent with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Respironics California, Inc. has initiated a recall of the V60 Ventilator due to a software issue on the V60 Power Management Board Assembly. The V60 Ventilator is an assist ventilator intended to augment patient breathing for spontaneously breathing individuals who require mechanical ventilation, including patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in hospital or other institutional settings.
The recall is being conducted because if a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator. This defect poses a risk to patients who rely on the device for respiratory support.
The recall affects 19,200 units total, with 12,060 units distributed in the United States and the remainder distributed worldwide. The devices are intended for use by qualified medical professionals, such as physicians, nurses, and respiratory therapists, for pediatric patients weighing 20kg or greater and adult patients.
The recalled product
- Product
- Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a)…
- Manufacturer
- Respironics California Inc
- Category
- Medical Device — Ventilator
Distribution
Distributed nationwide across the United States.
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