Z-0479-2022Class II

Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032

Name: Z-0479-2022 Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Creator: Ptw North America Corporation
Published: 2021-08-27
License: https://open.fda.gov/license/

PTW North America Corporation / initiated 2021-08-27 / Terminated / root cause: software

FDA source

PTW NORTH AMERICA CORPORATION began a recall of Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032 on 2021-08-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0479-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-27
Posted: 2022-01-11
Terminated: 2024-02-09
Recalling firm: PTW North America Corporation
Product: Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Product code: IYE Accelerator, Linear, Medical
Reason for recall: 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
Root cause tag: software
FDA root cause: Software design
Action: PTW US notified customer Urgent Safety Notice via email and telephone on 8/27/20. Letter states reason for recall, health risk and action to take: PTW will provide free-of-charge software updates. Users who use BeamAdjust 2.2/ VeriSoft 8.0 according to the above described application must update the software to VeriSoft 8.0.1/BeamAdjust 2.2.1 prior to further use of the software. For all other users PTW recommends using BeamAdjust 2.2.1/VeriSoft 8.0.1 too. Until the software updates are available PTW recommends avoiding the air density correction method. As a workaround, if air density correction should still be applied a manually calculated air density correction value can be entered as a kUser keeping kTP untouched (kTP =1.000 !). Please also note, machine QA measurements performed with PTW detector arrays within the PTW software MultiCheck are not affected. TW has fixed the bug in the software and provides all affected users with software updates.
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of CO.
Product codes and lots: S/N :AU2001094-1 UDI: EPTWS0700090 VeriSoft ;EPTWS0700090 BeamAdjust

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0479-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0479-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-11

Product code IYE

K160405Class IIOctavius I, Octavius II, Octavius III, Octavius 4DPtw-Freiburg Physikalisch-Technische-Werkstaetten / cleared 2017-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)