Recall Z-0548-06 ยท MKJ Automated External Defibrillators (Non-Wearable)
Medtronic Emergency Response Systems, Inc.
LIFEPAK EXPRESS defibrillator
| Date | Feb 23, 2006 (initiated Jan 31, 2006) |
| Status | Terminated |
| Reason | One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 20,525 devices total - CR Plus and LIFEPAK Express |
| Distribution | Units were distributed worldwide to public access environments. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.