LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK C
Summary
The FDA issued a Class II for LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 88 by Physio-Control, Inc.. Reason: Due to required inspections not being performed on products/units that have gone through servicing..
Details
Source
Device Recall
External ID
Z-2499-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.
Lot/Code Info: Part / Catalog Numbers / UDI-DI code / Serial Number: CR2-2-001451 / 99512-001434 / 883873785911 / 49638156
Quantity Affected: 1 unit
Reason for Recall
Due to required inspections not being performed on products/units that have gone through servicing.
Distribution
U.S. Nationwide distribution in the states of CO and MT.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-22
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 258 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-2499-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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