Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one device is once every 20 months. For use on persons requiring defibrillation therapy.
FDA Recall Z-2030-2009 · Posted 2009-09-14
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Recalling FirmPhysio Control, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2009-07-31
Date Terminated2013-03-15
Product Quantity34 devices (2 domestically & 32 internationally)
Reason for Recall
The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System(SAS) to not analyze the ECG rhythm correctly thus preventing the device from delivering therapy.
Firm Action
Physio-Control, Inc. notified Customers by phone beginning August 18, 2009. In addition, the recalling firm Issued an "Urgent Medical Device Recall" letter dated August 2009 informing Customers of the affected product and informing them that a Physio-Control representative will call and arrange for immediate device replacement.
For further information, contact Physio-Control Customer Care at 1-800-442-1142.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- US (DC and MN) and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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