Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external defibrillator deployed primarily in p
FDA device recall Z-2030-2009 · posted 2009-09-14 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 34 devices (2 domestically & 32 internationally)
- Distribution
- Worldwide Distribution -- US (DC and MN) and Japan.
- Date initiated
- 2009-07-31
- Date posted
- 2009-09-14
- Date terminated
- 2013-03-15
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR (K011144) | Medtronic Physio-Control Corp. | 2001-12-03 |