| Date Initiated by Firm | May 05, 2004 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on May 06, 2006 |
| Recall Number | Z-1107-04 |
|---|
| Recall Event ID |
29025 |
| 510(K)Number | K012274 |
|---|
| Product Classification |
Automated External Defibrillators (Non-Wearable) - Product Code MKJ
|
| Product | LIFEPAK 12 defibrillator/monitor
Part Numbers:
VLP12-02-000000 through VLP12-02-005003,
AVLP12-02-000000 through AVLP12-02-005003,
DVLP12-02-000000 through DVLP12-02-005003,
EVLP12-02-000000 through EVLP12-02-005003,
FVLP12-02-000000 through FVLP12-02-005003,
LVLP12-02-000000 through LVLP12-02-005003,
PVLP12-02-000000 through PVLP12-02-005003,
UVLP12-02-000000 through UVLP12-02-005003 |
|---|
| Code Information |
Non-continuous Serial Numbers between 1178083 and 305080962. |
| FEI Number |
3015876
|
Recalling Firm/
Manufacturer |
Medtronic Physio Control Corp
11811 Willows Rd NE
Redmond
WA
98073
|
| For Additional Information Contact | Michael A. Willingham
800-442-1142 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | 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. |
|---|
| Quantity in Commerce | 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. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
|
| 510(K) Database | 510(K)s with Product Code = MKJ
|
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