The LIFEPAK12 Defibrillator/Monitor. The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisor
FDA device recall Z-1548-2011 · posted 2011-03-04 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- L1FEPAK 12 Operating Instructions that describe the process for disconnecting the device from AC (wall) power are not always being followed. When the instructions are not followed and the Power ON button is pushed within 2 seconds after disconnecting the device from AC power, the service indicator will illuminate and the device may fail to charge the defibrillator and/or initiate pacing.
- Action taken
- Physio Control, Inc. began mailing the URGENT-MEDICAL DEVICE INFORMATION letter to their consignees on October 1, 2010. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were advised to follow the current LIFEPAK 12 Operating Instructions-Section 7.5-AC Power Adapter Operation and wait at least 2 seconds to push the Power ON button after disconnecting the device from AC power. If the instructions are not followed and the Power ON button is pushed within 2 seconds after disconnecting the device from AC power and the service indicator illuminates, it's important to be aware that turning the device off, then back on again, will reset the device and restore full functionality. The complete copy of the current LIFEPAK 12 Operating Instructions can be downloaded from the company's website at www.physio-control.com/products/ defibrillators, Select LIFEPAK 12, Select Documents. The consignees can call the firm's Technical Support Team at 1-800-442-1142, option 5, between 6:00 A.M. to 4:00 P.M. (Pacific), Monday - Friday.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 39, 180 units (17168 units internationally and 22012 units in US)
- Distribution
- Worldwide Distribution - USA and the countries of ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, H
- Date initiated
- 2010-10-01
- Date posted
- 2011-03-04
- Date terminated
- 2012-04-05
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM (K010918) | Medtronic Physio-Control Corp. | 2001-08-23 |