Device recall
Z-0745-2019: MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in…
FDA device recall · Class II · Bayer Medical Care, Inc.
Key facts
| Recall number (Z-number) | Z-0745-2019 |
|---|---|
| Recall event | 81808 |
| Product | MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S… |
| Product code | DXT |
| Recalling firm | Bayer Medical Care, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2020 |
| 510(k) numbers | K023183, K112086, K173773, K903390 |
| FEI number | 2520313 |
At a glance
- 1–9 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