Device recall
Z-0568-04: The device is labeled as AMS TAPSYSTEM Model 2A Esophageal Pulse generator (used…
FDA device recall · Class II · Cardiocommand Inc.
Key facts
| Recall number (Z-number) | Z-0568-04 |
|---|---|
| Recall event | 27606 |
| Product | The device is labeled as AMS TAPSYSTEM Model 2A Esophageal Pulse generator (used in the Operating Room at Hospitals) and is labeled as ''MANUFACTURED FOR ARZCO MEDICAL SYSTEMS, INC. PO BOX 1048, TAMPA, FL 33601 1-800-231-6370 MODEL S/N'' |
| Product code | LPA |
| Recalling firm | Cardiocommand Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2011 |
| PMA numbers | P840002, P840002S9 |
| FEI number | 1927197 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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