Hard shell carry case for the LIFEPAK 500 AED.
FDA device recall Z-0004-06 · posted 2005-10-04 · Terminated
Recall details
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Reason for recall
- Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).
- Action taken
- On 7/12/05 the firm issued a letter to customers instructing the customers to inspect the cases for blocked vent. If the customer noted that the vent was blocked, to contact the firm for a replacement case. The firm provided response cards for the customers to return stating they had inspected their units.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 4608 cases
- Distribution
- Cases were distributed nationwide and internationally.
- Date initiated
- 2005-07-12
- Date posted
- 2005-10-04
- Date terminated
- 2006-06-26
- Location
- Redmond, WA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM (K010918) | Medtronic Physio-Control Corp. | 2001-08-23 |