LIFEPAK 12 defibrillator/ monitors biphasic
FDA device recall Z-0495-05 · posted 2005-02-03 · Terminated
Recall details
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Reason for recall
- The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.
- Action taken
- The firm sent 4000 User Notification letters via FED-EX on 1/15/2005 and approximately 3000 on 1/17/2005. The User Notification letters informed consignees about the two complaints and described the firm''s findings from their investigation into the problem. The letters also requested the users check the default energy settings; report back to the firm any discrepancies found; and reset the discrepant settings which differed from the user programmed settings.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 28,835 devices distributed in the U.S.; 15,613 devices distributed internationally
- Distribution
- 28,835 devices were shipped to 6874 domestic consignees.
- Date initiated
- 2005-01-15
- Date posted
- 2005-02-03
- Date terminated
- 2006-05-06
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 12 (K040775) | Medtronic Physio-Control Corp. | 2004-04-23 |
| LIFEPAK 12 BIPHASIC (K991910) | Physio-Control Corp. | 1999-09-03 |