Recall Z-0413-2017 ยท KRG Programmer, Pacemaker
Sorin Group USA, Inc.
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.
| Date | Sep 29, 2016 |
| Status | Terminated |
| Reason | Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate. |
| Root cause | Software Design Change |
| Action | The firm, LivaNova, sent an "Urgent Field Safety Notice" dated 9/29/2016 to its customers. The notice described the product, problem, actions to be taken. The notice states that a Sorin representative will contact customers to upgrade the software in the facility's programmer. If customers have any questions, they are urged to call their LivaNova representative or contact LivaNova Technical Services at 877.663.7674. |
| Quantity | 586 programmers |
| Distribution | Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.