VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x
FDA Recall Z-0633-03 · Posted 2003-03-12
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Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2003-01-31
Date Terminated2003-09-17
Product Quantity12 units
Reason for Recall
The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.
Firm Action
On 1/16/03 and 2/4/03 (2nd notification) the firm initiated the recall and their notification was via letters to inform its consignees about the new VARiS version 6.2.27 release.
Root Cause
Software design
Distribution Pattern
Product was released for distribution to 7 hospitals in the US. Distribution was limited to the following States: CA, MA, NC, SC, PA, and LA. 1 (one) Canadian distribution includes Fraser Valley Cancer Center, Dept. of Radiation Oncology, 13750 96th Ave., Surrey, BC, V3V 1Z2, Canada. Foreign distribution includes Austria, Germany and Finland. The recall was appropriately extended to the user level; i.e., the hospitals/physicians who received the recalled product.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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