ViewRay MRIdian Linac System software anomalies in non-English versions
Viewray, Inc. is recalling MRIdian Linac System treatment delivery software in French, German, and Italian versions due to software anomalies affecting radiation therapy systems.
What this means for you
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: This FDA Class II recall affects software in a high-risk medical device used for radiation therapy. Although no illnesses or injuries are reported, software anomalies in such equipment represent a risk-of-harm product even without confirmed incidents, meeting the rubric criterion for High severity.
Plain-English summary
Viewray, Inc. is recalling versions of the treatment delivery system (TDS) software for the ViewRay MRIdian Linac System, an MRI image-guided radiation therapy device used for planning and delivering radiation therapy for lesions, tumors, and conditions throughout the body. The recalled software includes the French, German, and Italian language versions.
Specifically affected are the following software serial numbers: French version 214, 215, 226, and 240; German or Italian versions 203, 232, 108, and 244. These systems are distributed to healthcare facilities in France, Germany, Italy, and Switzerland.
The recall is prompted by software anomalies affecting the identified versions. The FDA has classified this recall as Class II.
The recalled product
- Product
- ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in th
- Manufacturer
- Viewray, Inc.
- Hazard
- Affected units
- 8
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 (4)
- French version of the TDS software affected serial numbers: 214
- 215
- 232
- 108 and 244
Distribution
Distribution scope not specified by the agency.
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