FDA recall Z-0296-2024

Physio-Control, Inc. · Class II · device

Product

LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051

Reason for recall

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

Distribution

US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.

Key facts

Status
Ongoing
Initiation date
2023-09-29
Report date
2023-11-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Redmond, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0296-2024