Recall Z-2579-2010 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
ela Medical Llc
Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy
| Date | Sep 27, 2010 (initiated Jun 7, 2010) |
| Status | Terminated |
| Reason | The Paradym CRT 8750 and CRT sonR 8770 device models have a software anomaly, which will cause the device to lose the ability to sense/pace and to deliver further therapy. The software anomaly could only occurs under a specific sequence of events. |
| Root cause | Software design |
| Action | Sorin Group issued a "Medical Device Correction" letter dated June 7, 2010 to consignees. The letter described the product, the problem, and actions to be taken by customers. A Sorin Group representative will contact customers to update the software. Prior to receiving the software update, customers should program the exercise AV delay to 40 ms, which will trigger a reset in the event of an anomaly. This will restore normal operation after shock delivery. If the anolmaly occurs on an implanted unit, a RV coil or SVC coil continuity test should be started, which will ensure that the device rec |
| Quantity | 215 |
| Distribution | Nationwide Distribution in the states of AZ, CA, FL, IA, LA, MA, MS,MO, NJ, NY, NC, OH, OK, PA, SC, TN, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.