The Recall Desk
SevereFDA (Devices)·Z-1013-2015·Announced 2015-02-04

Siemens Syngo RT Therapist Software Recall Due to Mistreatment Risk

Siemens is recalling Syngo RT Therapist software because a combination with CTVision may cause wrong offset calculations, leading to patient mistreatment.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device defect that can lead to patient mistreatment, which constitutes a significant injury risk under the rubric for Severe recalls.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling three units of Syngo RT Therapist software. The software is used with Siemens ARTISTE, ONCOR, and PRIMUS linear accelerator systems to deliver radiation for cancer treatment.

The recall is due to a potential error where the combination of CTVision with syngo RT Therapist or syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying these incorrect offsets can lead to patient mistreatment. Cone Beam imaging is not affected by this problem.

The affected units are distributed in Utah, Wisconsin, and New York. The specific units are identified by model number 08162815 and serial numbers 10010, 10046, and 10586. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address this issue.

The recalled product

Product
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • model # 08162815
  • serial #s 10010
  • 10046
  • 10586

Distribution

Distributed in 3 states:

Same manufacturer · Siemens Medical Solutions USA, Inc

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