FDA Device recall Z-0479-2022
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
- FDA Device
- Class II
- terminated
- Published 2022-01-19
On 2022-01-19 the FDA classified a Class II recall of Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032 by Ptw North America, citing when a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0479-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-27 |
| Published | 2022-01-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ptw North America |
| Distribution | US |
Product
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Reason
When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which affects patient plan verification results
Identifiers
| code_info | S/N :AU2001094-1 UDI: EPTWS0700090 VeriSoft ;EPTWS0700090 BeamAdjust |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0479-2022%22
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