Recall Z-0176-03 ยท LNX
Varian Brachytherary Virginia
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***
| Date | Dec 3, 2003 (initiated Oct 31, 2003) |
| Status | Terminated |
| Reason | The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient. |
| Root cause | Other |
| 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. |
| Quantity | 29 sets |
| Distribution | Software was distributed to end users nationwide and internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992762 | BRACHYVISION 6.0 Varian Assoc., Inc., Mar 9, 2000 |