Ray Station Radiation Therapy System Recalled for Dose Calculation Error
Ray Search Laboratories is recalling Ray Station 3.0, 3.5, and 4.0 systems due to a dose calculation error involving Elekta motorized wedges.
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: The recall involves a medical device with a dose calculation error, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ray Search Laboratories is recalling the Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5, and 4.0. The recall involves 195 units distributed in the United States. The affected software versions are 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, and 4.0.1.4.
The recall was initiated because the company identified an issue with dose calculation for Elekta motorized wedges. This error occurs when a wedge is used for a beam and the wedge angle differs from 60 degrees. The affected units were distributed in California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.
Healthcare facilities using these systems should contact Ray Search Laboratories for further instructions regarding the software update or replacement.
The recalled product
- Product
- Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- Affected units
- 195
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 (5)
- Software version and build numbers 3.0.0.251
- 3.5.0.16
- 3.5.1.6
- 4.0.0.14
- 4.0.1.4.
Distribution
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