Recall record at a glance
| Official record | Z-0106-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Report date | Oct 14, 2015 |
| Recall initiation date | Aug 11, 2015 |
| Quantity | 14 |
| Location | Malvern, PA, United States |
Official product description
Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.
Why the product was 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.
Distribution information
US Distribution to states of: MA, MO, OH, PA, UT, and WI.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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