Defibrillator servicing inspections not performed; Physio-Control LIFEPAK CR2 recalled
Physio-Control is recalling LIFEPAK CR2 defibrillators due to failure to perform required inspections on serviced units. Affected units were distributed in Colorado and Montana.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for a procedural quality control failure on a life-critical defibrillator. While no illnesses or injuries have been reported, the device is a high-risk product where undetected defects from missed inspections could result in device failure during emergency use.
Plain-English summary
Physio-Control, Inc. is recalling LIFEPAK CR2 defibrillators used by trained personnel for patients in cardiac arrest. The recall is being issued because required quality inspections were not performed on units that underwent servicing.
The affected LIFEPAK CR2 defibrillators have Part Number CR2-2-001451, Catalog Number 99512-001434, UDI-DI 883873785911, and Serial Number 49638156. These units were distributed nationwide in Colorado and Montana.
The LIFEPAK CR2 is a medical device intended for trained users to deliver electrical therapy to patients with cardiac arrhythmias. The failure to perform required post-service inspections means that defects in these units may not have been detected.
Facilities and personnel who have received or serviced LIFEPAK CR2 defibrillators with the affected serial number should contact Physio-Control, Inc. for instructions on return or replacement.
The recalled product
- 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 breathin
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Hazard
- inspection-failure
- device-failure
Distribution
Distributed nationwide across the United States.
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