LIFEPAK 500 automated external defibrillator (AED)
FDA device recall Z-0546-06 · posted 2006-02-22 · Terminated
Recall details
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Reason for recall
- Component leads may have intermittent connection to the printed circuit board assembly pads - which could render the device inoperative.
- Action taken
- On 2/1/06 the firm issued an UREGENT MEDICAL DEVICE CORRECTION letter to customers via certified return receipt. The letter advised customers of the issue and recommended customers inspect their AED at least weekly. The letter also advised customers what to do when readiness indicator displays certain symbols. The firm''s representatives will visit customers to replace the main circuit board assembly.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 2100 domestically, 1980 internationally
- Distribution
- Devices were distributed domestically to first responder type consignees and internationally to distributors.
- Date initiated
- 2006-02-01
- Date posted
- 2006-02-22
- Date terminated
- 2008-03-06
- Location
- Redmond, WA
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