Device recall
Z-0077-2012: Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable…
FDA device recall · Class II · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-0077-2012 |
|---|---|
| Recall event | 59948 |
| Product | Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measuring pressure between -100 mmHg and +500 mmHg with an accuracy of +/-5 mmHg from -100 mmHg to +300 mmHg and +/-10 mmHg from +301 to +500 mmHg. The Pressure Display Box has an upper and lower alarm setting. The… |
| Product code | DXS |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 11, 2012 |
| 510(k) numbers | K852232 |
| FEI number | 1000116158 |
At a glance
- 1–9 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