Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medic
Summary
The FDA issued a Class II for Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, ev by PTW-FREIBURG. Reason: Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate .
Details
Source
Device Recall
External ID
Z-1181-2024
Action Date
2024-02-28
Status
Ongoing
Category
device
Product Description
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
Lot/Code Info: UDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1
Quantity Affected: 1 US; 65 worldwide
Reason for Recall
Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.
Distribution
GA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-08
Company
Freiburg Im Breisgau, N/A
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 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
PTW-FREIBURG has 2 FDA actions in our database, including 2 recalls.
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-FREIBURG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PTW-FREIBURG have FDA actions?
PTW-FREIBURG has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1181-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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