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Terminated

BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Labeled in part ***Varian Medical Systems Inc. Oncology Systems***

FDA Recall Z-0176-03 · Posted 2003-12-03

Recalling FirmVarian Brachytherary Virginia
Recall StatusTerminated
Product CodeLNX
Date Initiated2003-10-31
Date Terminated2003-12-15
Product Quantity29 sets

Reason for Recall

The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient.

Firm Action

The recalling firm notified consignees by Customer Technical Bulletin on 5/21/03 and additionally by 'URGENT MEDICAL DEVICE CORRECTION LETTER' on 10/31/03. The notifications caution consignees about the need to fully understand scaling functionality and to check scaling for every treatment plan. The notification further explains that the next software release will be modified to include a screen message that appears whenever automatic magnification appears.

Root Cause

Other

Distribution Pattern

Software was distributed to end users nationwide and internationally.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992762BRACHYVISION 6.0Varian Assoc., Inc. · 2000-03-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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