FDA Enforcement
Class II
Ongoing
LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Recall: Z-0296-2024
·
Reported November 22, 2023
Enforcement
- Recall Number
- Z-0296-2024
- Event ID
- 93233
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Physio-Control, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 22, 2023
- Initiation Date
- September 29, 2023
- Classification Date
- November 14, 2023
- Address
- 11811 Willows Rd Ne, N/A, Redmond, WA, 98052-2003, United States
Description
LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Reason
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Code Info
UDI: 00883873988022/ Serial number: 38370274
Distribution
US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
Quantity
1 unit