Data Foundry

Medical device recalls 2022

Software BeamAdjust version 2 — Class II medical device recall Z-0479-2022

Terminated recall by PTW NORTH AMERICA CORPORATION, reported 2022-01-19, distributed nationwide. When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a

Recall numberZ-0479-2022
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPTW NORTH AMERICA CORPORATION, Boonton, NJ, United States
Recall initiated2021-08-27
Classified2022-01-11
Reported by FDA2022-01-19
Terminated2024-02-09
DistributedNationwide (US)
Quantity1 units
Reason classessoftware
Model numbersS070009, S080032

Product

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

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0479-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.