Physio-Control LIFEPAK 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor series is a battery operated portab
FDA device recall Z-1858-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- The LIFEPAK12 defibrillator/monitor series (LP12) contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock.
- Action taken
- Starting May 8, 2008, letters were hand-delivered by the firm's service representatives as they visited customer sites to perform on-site service for affected units. Customers who had not been visited by May 16th were mailed a Certified Receipt letter on May 16, 2008. The letter explained the recall and notified customers that Physio Control was conducting a Field correction to replace all affected Biphasic PCBA. The firm recommends customers continue to perform therapy cable or Standard Paddles Defibrillation Check (monthly or as needed); to have a backup device available until their device is updated; and if no backup device is available, a loaner would be provided by the firm upon request. Contact Technical Support at 1-800-442-1142, option 5 - 6:00 am to 4:00 pm (Pacific), Monday -Friday or visit www.Physio-Control-notices.com/LP12.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 1,710 Units
- Distribution
- Product distributed nationwide to 5 Department of Defense accounts, 1 VA account, 5 government accounts, 49 hospitals, 223 first responders, and 1 direct account. 8 foreign accounts include: NETHERLAN
- Date initiated
- 2008-05-08
- Date posted
- 2008-09-11
- Date terminated
- 2013-09-04
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 12 BIPHASIC (K991910) | Physio-Control Corp. | 1999-09-03 |