| Date Initiated by Firm | April 05, 2004 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on January 06, 2005 |
| Recall Number | Z-0938-04 |
|---|
| Recall Event ID |
28737 |
| 510(K)Number | K012274 |
|---|
| Product Classification |
Dc-Defibrillator, Low-Energy, (Including Paddles) - Product Code LDD
|
| Product | LIFEPAK 12 defibrillator/monitor. |
|---|
| Code Information |
Part numbers VLP12, UVLP12, EVLP12, DVLP12, AVLP12, and any of these may have five to eight digits after the base number. Serial numbers can be obtained from the firm or FDA''s Seattle District Recall Coordinator |
Recalling Firm/
Manufacturer |
Medtronic Physio Control Corp
11811 Willows Rd NE
Redmond WA 98073
|
| For Additional Information Contact | John A. Parks
425-867-4681 |
|---|
Manufacturer Reason
for Recall | Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Letters dated April 2004 were sent to customers on 4/6/04. The letter explains that a service representative will visit the customer and check the capacitor. |
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| Quantity in Commerce | 2885 |
|---|
| Distribution | Devices were distributed to hospitals and medical centers throughout the US. The firm also distributed units 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 = LDD
|
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