Device recall
Z-0266-06: Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber…
FDA device recall · Class II · ela Medical Llc
Key facts
| Recall number (Z-number) | Z-0266-06 |
|---|---|
| Recall event | 34003 |
| Product | 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. |
| Product code | DXY |
| Recalling firm | ela Medical Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 28, 2007 |
| PMA numbers | P950029, P950029S017 |
| FEI number | 2182863 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database