PTW Freiburg Recalls VERIQA RT MonteCarlo 3D Software Due to Bolus Display Error
PTW Freiburg is recalling VERIQA RT MonteCarlo 3D software because it fails to clearly display bolus inclusion during secondary dose calculation, which may lead to incorrect dose delivery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the delivery of radiation to the wrong tissue depth, which constitutes a significant injury risk.
Plain-English summary
PTW Freiburg is recalling the VERIQA RT MonteCarlo 3D v3 software, model S070031.520, version 3.1.18. The recall involves two units distributed worldwide, including in the United States (Georgia and New York) and numerous international locations.
The software contains a defect where, if a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly. This lack of clear display may lead users to incorrectly omit the bolus during treatment, resulting in the prescribed dose being delivered to the wrong tissue depth.
Healthcare facilities and users of this software should contact PTW Freiburg for further instructions on how to address the software defect.
The recalled product
- Product
- Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
- Manufacturer
- PTW FREIBURG
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model/Catalog Number: S070031.520
- UDI-DI: +EPTWS070031Q5200
- Software Version 3.1.18
Distribution
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