BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Med
FDA device recall Z-0176-03 · posted 2003-12-03 · Terminated
Recall details
- Recalling firm
- Varian Brachytherary Virginia
- Reason for recall
- The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient.
- Action taken
- 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
- Status
- Terminated
- Product code
- LNX
- Quantity affected
- 29 sets
- Distribution
- Software was distributed to end users nationwide and internationally.
- Date initiated
- 2003-10-31
- Date posted
- 2003-12-03
- Date terminated
- 2003-12-15
- Location
- Charlottesville, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRACHYVISION 6.0 (K992762) | Varian Assoc., Inc. | 2000-03-09 |