Device recall
Z-1493-2019: TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part…
FDA device recall · Class II · Abbott Laboratories Inc. (St Jude Medical)
Key facts
| Recall number (Z-number) | Z-1493-2019 |
|---|---|
| Recall event | 82727 |
| Product | TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP) |
| Product code | OAE |
| Recalling firm | Abbott Laboratories Inc. (St Jude Medical) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2021 |
| PMA numbers | P130026 |
| FEI number | 1000139754 |
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