Summary
The FDA issued a Class II for LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 by Physio-Control, Inc.. Reason: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues..
Details
Source
Device Recall
External ID
Z-0299-2024
Action Date
2023-11-22
Status
Ongoing
Category
device
Product Description
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Lot/Code Info: UDI: 00883873911648/ Serial number: 40644322 40644323 40644331 42221204 42934131
Quantity Affected: 5 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-29
Company
Redmond, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Physio-Control, Inc. has 24 FDA actions in our database, including 22 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Physio-Control, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Physio-Control, Inc. have FDA actions?
Physio-Control, Inc. has 24 FDA actions in our database, including 22 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0299-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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