FDA recall Z-2631-2023

Philips Respironics, Inc. · Class I · device

Product

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.

Distribution

US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.

Key facts

Status
Ongoing
Initiation date
2023-08-25
Report date
2023-10-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Murrysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2631-2023