The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3202488-000, U3202487-000, 3202
FDA device recall Z-1722-2011 · posted 2011-03-18 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- A component failure on the AC power supply assembly results in "NO AC POWER" operation. A failure of AC power can result in a delay of defibrillation therapy if backup battery power is depleted.
- Action taken
- PhysioControl, Inc. began sending an Urgent Medical Device Correction letter via certified receipt to all affected customers describing the potential issue. Customers were advised to keep the defibrillators in service and to follow the daily Operator's Checklist. All power supplies will be updated. For questions customers were instructed to contact Technical Support at 1-800-442-1142. For questions regarding this recall call 425-867-4000.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 53550 units
- Distribution
- Worldwide distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MI, MD, MI, NC, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY and the coutnr
- Date initiated
- 2010-05-27
- Date posted
- 2011-03-18
- Date terminated
- 2014-09-29
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 20E (K073089) | Physio-Control, Inc. | 2008-07-29 |
| MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER (K012274) | Medtronic Physio-Control Corp. | 2002-02-05 |