LIFEPAK 500 automated external defibrillator
FDA device recall Z-0886-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Medtronic Physio Control Corp
- Reason for recall
- Potential for batteries to malfunction due to battery cell rupture.
- Action taken
- On 4/2/04 the firm initiated telephone contacts to customers to determine if the customer potentially has suspect battery. If so, the customer will be faxed a letter describing how to remove the battery to check for the code date. If customer confirms they have suspect battery, a new battery will be shipped to customer.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 7028
- Distribution
- The firm distributed devices nationwide to various hospitals, medical centers, and businesses. The firm also distributed to foreign customers in Australia, Argentina, Brazil, Canada, China, Greece, Ho
- Date initiated
- 2004-04-02
- Date posted
- 2004-07-20
- Date terminated
- 2005-01-06
- 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 |
|---|---|---|
| MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR (K012428) | Medtronic Physio-Control Corp. | 2001-09-28 |