Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Summary
The FDA issued a Class II for Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version by PTW NORTH AMERICA CORPORATION. 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 specif.
Details
Source
Device Recall
External ID
Z-0479-2022
Action Date
2022-01-19
Status
Terminated
Category
device
Product Description
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Lot/Code Info: S/N :AU2001094-1 UDI: EPTWS0700090 VeriSoft ;EPTWS0700090 BeamAdjust
Quantity Affected: 1 unit
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
Distribution
US Nationwide distribution in the state of CO.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-27
Company
Boonton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 106 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PTW NORTH AMERICA CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PTW NORTH AMERICA CORPORATION have FDA actions?
This is the only FDA action we have on record for PTW NORTH AMERICA CORPORATION in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0479-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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