Device product
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.
Z-2499-2025
Product summary
- Event
- Event 96949
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2499-2025
Official wording
Reason: Due to required inspections not being performed on products/units that have gone through servicing.
Code information: Part / Catalog Numbers / UDI-DI code / Serial Number: CR2-2-001451 / 99512-001434 / 883873785911 / 49638156
Distribution pattern: U.S. Nationwide distribution in the states of CO and MT.
Derived failure modes
-
Unknown
Due to required inspections not being performed on products/units that have gone through servicing.