RayStation 10B SP1 recalled over radiation dose that fails to invalidate
RaySearch Laboratories is recalling RayStation/RayPlan model 10.1.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a calculated radiation dose that is not invalidated when it should be can be used for planning, and no injuries are reported.
Plain-English summary
RayStation/RayPlan, a radiation therapy treatment planning system, model 10.1.1, software version RayStation 10B SP1, is being recalled by RaySearch Laboratories AB.
The record states there is a potential for the invalidation for calculated radiation dose not to work as intended for certain Regions of Interest (ROIs). The issue occurs for some ROIs which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
The record's quantity field reads 0, so no unit count is given here. Rather than naming territories, the record refers to attached distribution lists, 'Distribution list 167168 US - updated' and 'Distribution list 167168 OUS'. UDI, GTIN and serial numbers are recorded in the enforcement record. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Sites should follow RaySearch's instructions.
The recalled product
- Product
- SQ40S Blood Transfusion Filter
- Manufacturer
- GVS TM, Inc
- Affected units
- 2,720
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 (1)
- Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142
Distribution
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