Device recall
Z-2968-2018: McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological…
FDA device recall · Class II · McKesson Israel Ltd.
Key facts
| Recall number (Z-number) | Z-2968-2018 |
|---|---|
| Recall event | 80723 |
| Product | McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson… |
| Product code | DQK |
| Recalling firm | McKesson Israel Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 23, 2021 |
| 510(k) numbers | K131497 |
| FEI number | 3007784465 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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