LIFEPAK EXPRESS defibrillator
FDA device recall Z-0548-06 · posted 2006-02-23 · Terminated
Recall details
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Reason for recall
- One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
- Action taken
- On 1/31/06 the firm sent a letter flagged URGENT-MEDICAL DEVICE RECALL to their customers via certified return receipt. The letter advised customers of the problem and requested the customers inspect their units at least weekly. The customers are provided additional guidance if they see certain symbols as described in the letter. The firm''s service personnel will visit the customers, remove and replace units.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 20,525 devices total - CR Plus and LIFEPAK Express
- Distribution
- Units were distributed worldwide to public access environments.
- Date initiated
- 2006-01-31
- Date posted
- 2006-02-23
- Date terminated
- 2011-01-17
- Location
- Redmond, WA
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