FDA Device Recall Z-2631-2023
Philips Respironics, Inc. · Murrysville, PA
Class I — life-threatening Ongoing
Device
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Reason for recall
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
Recall record
- Recall number
Z-2631-2023- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
- Recall initiated
- 2023-08-25
- Classified by FDA Center
- 2023-09-28
- FDA published
- 2023-10-04
- Recalling firm
- Philips Respironics, Inc.
- Firm location
- Murrysville, PA
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.