Recall Z-2030-2009
Physio Control, Inc. · initiated July 31, 2009
Product
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.
Codes / lots: Serial Numbers: 37026963, 37026983, 37026984, 37026997, 37027002, 37027008, 37027039, 37027040, 37027049, 37027053, 37027063, 37027065, 37027066, 37027070, 37027071, 37027073, 37027075, 37027090, 37027099, 37027105, 37027122, 37027197, 37027529, 37027569, 37031393, 37037850, 37037893, 37037986, 37038002, 37038211, 37038365, 37135986, 37154526 and 37154638.
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-2030-2009
- Initiated
- July 31, 2009
- Posted by FDA
- September 14, 2009
- Terminated
- March 15, 2013
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 34 devices (2 domestically & 32 internationally)
- Distribution
- Worldwide Distribution -- US (DC and MN) and Japan.
- Recalling firm
- Physio Control, Inc., Redmond, WA