FDA Device Recall Z-0662-2022
Respironics California, LLC · Carlsbad, CA
Class I — life-threatening Ongoing
Device
Philips Respironics V60 Ventilator Part Number 1053617
Reason for recall
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
Recall record
- Recall number
Z-0662-2022- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A
- Recall initiated
- 2022-01-24
- Classified by FDA Center
- 2022-02-25
- FDA published
- 2022-03-09
- Recalling firm
- Respironics California, LLC
- Firm location
- Carlsbad, CA
Operational response
A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.
For the official FDA enforcement record, see FDA's Recall Search.