PTW NORTH AMERICA CORPORATION Recall 89314
Description: Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
PTW NORTH AMERICA CORPORATION Recall 89314 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0479-2022 |
| Event ID | 89314 |
| Event Description | Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of CO. |
| Quantity | 1 unit |
| Recall 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 |
| Device Classification | 20220119 |
| Device Code Info | S/N :AU2001094-1 UDI: EPTWS0700090 VeriSoft ;EPTWS0700090 BeamAdjust |
| Center Classification Date | 20220111 |
| Recall Initiation Date | 20210827 |
| Recalling Firm | PTW NORTH AMERICA CORPORATION |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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