Reported Jan 19, 2022 · Terminated
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Ptw North America Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PTW NORTH AMERICA CORPORATION · 6 Mars Ct Rm Unit 5 · Boonton, NJ · 07005-9309
Is this the product you have?
- Software BeamAdjust version 2.2
- Catalog NoS070009 Software VeriSoft version 8.0
- Catalog NoS080032
- Lot codes and dates
- S/NAU2001094-1
- UDI
EPTWS0700090 VeriSoftEPTWS0700090 BeamAdjust
- Amount recalled
- 1 unit
Where it was sold
- Nationwide
- CO
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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