Device recall
Z-2577-2023: BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are…
FDA device recall · Class II · PTW-FREIBURG
Key facts
| Recall number (Z-number) | Z-2577-2023 |
|---|---|
| Recall event | 92879 |
| Product | BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI… |
| Product code | IYE |
| Recalling firm | PTW-FREIBURG |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K160405 |
| FEI number | 3007360740 |
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