Syngo RT Oncologist recall: Software Issue
Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and…
Why was Syngo RT Oncologist recalled?
This update is intended to provide a software update for the Syngo RT Oncologist, which is currently running SW version 4.2 or 4.3. The safety-related issues, which were described in the Customer Safety Notice distributed as UFSN-RTT/RTO 4.3 Adaptive Targeting [Auto-registration]. The update contains several important safety and performance fixes.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number of device- 10568604, serial numbers: 10206 10337 10338 10100 10289 10197 10131 10179 10184 10158 10235 10236 10080 10296
- Product
- Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 14
- Distribution
- US Distribution to states of: MA, MO, OH, PA, UT, and WI.
- Recall date
- October 14, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)