Recall Z-1017-05 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
St Jude Medical
Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343).
| Date | Jul 19, 2005 (initiated Jun 17, 2005) |
| Status | Terminated |
| Reason | Two corrections to firmware due to Skipped-Charge Shock and Sensor Noise Anomaly are being made with one noninvasive upgrade. |
| Root cause | Other |
| Action | Recall was by letter to Physicians sent by FEDEX. Follow-up upgrade to programmers will be done by firm representatives to the new version 4.8.5. |
| Quantity | 30,000 domestically, 11,684 internationally |
| Distribution | Nationwide and Sweden, Canada, Australia, New Zealand. South America and Asia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.