LIFEPAK EXPRESS defibrillator
This recall has been terminated (originally issued February 23, 2006).
- Recall Initiated
- January 31, 2006
- Posted
- February 23, 2006
- Terminated
- January 17, 2011
- Recall Number
- Z-0548-06
- Quantity
- 20,525 devices total - CR Plus and LIFEPAK Express
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
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.
Distribution
Units were distributed worldwide to public access environments.
Lot / Code Info
Part number 3202177-00 through -002 Serial numbers listed above with the CR Plus
Root Cause
Nonconforming Material/Component
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.