Varian Medical Systems Inc
04 رجب 1428 هـ الموافق 18 يوليو 2007 م
| Recalling Firm / Manufacturer |
Varian Medical Systems Inc |
| Product |
LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1. |
| Code Information |
S/Ns: HZ30001 HZ30020 HZ30021 HZ30033 HZ30054 HZ30061 HZ30108 HZ30139 HZ30144 HZ30167 HZ30171 HZ30178 HZ30207 HZ30208 HZ30224 HZ30230 HZ30251 HZ30265 HZ30280 HZ30283 HZ30293 HZ30294 HZ30299 HZ30312 HZ30330 HZ30342 HZ30349 HZ30368 HZ30398 HZ30403 HZ30404 HZ30407 HZ30422 HZ30426 HZ30460 HZ30461 HZ30462 HZ30485 HZ30495 HZ30507 HZ30508 HZ30509 HZ30511 HZ30513 HZ30520 HZ30531 HZ30537 HZ30540 HZ30556 HZ30557 HZ30571 HZ30572 HZ30573 HZ30574 HZ30588 HZ30604 HZ30612 HZ30617 HZ30620 HZ30640 HZ30646 HZ30649 HZ30656 HZ30670 HZ30674 HZ30675 HZ30681 HZ30684 HZ30698 HZ30703 HZ30727 HZ30731 HZ30740 HZ35070 HZ39020 HZ39066 HZ39071 HZ39165 HZ39997 |
| Reason of Recall |
A software anomaly in a medical device used for patient treatment could result in accidental or unintended exposure radiation exposure. The tilt rotation compensation algorithm does not adequately compensate for the tilt rotation. |
| Date Recall Initiated |
March 09, 2007 |
| Action |
The recalling firm notified medical device end users by letter dated 03/09/07 and advised of the software anomaly and provided details for user corrective action pending software upgrade by the manufacturer. Firm Initiated recall is ongoing. |
| Contact |
Varian Medical Systems
01 / 2772126 |
| Source of Information |
U.S. FDA |
| SFDA Comments |
SFDA urges all hospitals that have devices subjected to recall, to contact the company. |