Recall Z-1148-2007 ยท MKT Hepatitis Viral B Dna Detection
Medtronic Emergency Response Systems, Inc.
biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)
| Date | Aug 4, 2007 (initiated Jun 13, 2007) |
| Status | Terminated |
| Reason | Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J. |
| Root cause | Other |
| Action | On June 13, 2007 the recalling firm sent a letter dated June 11, 2007, titled URGENT - MEDICAL DEVICE CORRECTIVE ACTION. The letter advises of the situation, recommends to the consignee to set defibrillator to FIXED Sequence Protocol and to contact the firm for a FLEXIBLE Sequence Energy Protocol. The letter provides an instruction sheet and a response sheet to be faxed back to the company. |
| Quantity | 59,996 devices |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955854 | LIFEPAK 500 Physio-Control Corp., Nov 4, 1996 |