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Viewray, Inc. Recall 87865

Description: 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 the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.

Viewray, Inc. Recall 87865 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1836-2021
Event ID87865
Event DescriptionViewRay 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 the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.
Product TypeDevices
DistributionInternational distribution only to the countries of France, Germany, Italy, and Switzerland.
Quantity8 versions
Recall ReasonSoftware anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
Device Classification20210616
Device Code InfoFrench version of the TDS software affected serial numbers: 214, 215, 226 and 240 German or Italian versions of the TDS software affected serial numbers: 203, 232, 108 and 244
Center Classification Date20210609
Recall Initiation Date20210504
Recalling FirmViewray, Inc.
Initial Notification E-Mail
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