Recall Z-0266-06 ยท DXY Implantable Pacemaker Pulse-Generator
ela Medical Llc
Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.
| Date | Dec 2, 2005 (initiated Oct 25, 2005) |
| Status | Terminated |
| Reason | Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process. |
| Root cause | Other |
| Action | A Dear Doctor letter, dated 10/25/05, was sent to all affected doctors. The letter describes the failures and mentions that pacemaker depend patients implanted with devices manufactured in the first group could require prophylactic replacement. |
| Quantity | 17 |
| Distribution | Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.