LIFEPAK 12 defibrillator/monitor Part Numbers: VLP12-02-000000 through VLP12-02-005003, AVLP12-02-000000 through AVLP12-
FDA device recall Z-1107-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Medtronic Physio Control Corp
- Reason for recall
- Therapy cable doesn't meet firm's standards/may not maintain connections sufficient to support ECG monitoring, external pacing or defibrillation; ECG connector with higher than normal connection resistance resulting in intermittent ECG signal; therapy connector has potential for impact damage.
- Action taken
- The firm reviewed records and/or contacted customers by telephone to verify affected devices used in the out of hospital mobile environment. All affected customers were notified by a letter dated May 2004. The firm''s service representative will contact customers to inspect and correct the devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 20,676 domestic, 19,899 international
- Distribution
- The firm distributes to distributors, hospitals, EMT-Ds and paramedics nationwide. The firm also distibutes the product internationally.
- Date initiated
- 2004-05-05
- Date posted
- 2004-07-20
- Date terminated
- 2006-05-06
- Location
- Redmond, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER (K012274) | Medtronic Physio-Control Corp. | 2002-02-05 |