FDA Medical Device Recalls (openFDA)
PTW NORTH AMERICA CORPORATION: Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
- Recall number
- Z-0479-2022
- Recalling firm
- PTW NORTH AMERICA CORPORATION
- Product
- Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
- Status
- Terminated
- Initiated
- 2021-08-27
- Posted
- not on file
- Terminated
- 2024-02-09
- 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
- 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
- 1 unit
- Distribution
- US Nationwide distribution in the state of CO.
- Lot, serial or model codes
- S/N :AU2001094-1 UDI: EPTWS0700090 VeriSoft ;EPTWS0700090 BeamAdjust
- 510(k) numbers
- ["K160405"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3019665367
- Firm city
- Boonton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28