Agency classClass IIOur severity:Severe FDA (Devices)·Z-3005-2020·Announced 2020-09-30

Siemens Syngo.via RT Image Suite Software Recall for Calibration Offset Error

Siemens is recalling Syngo.via RT Image Suite software due to a calibration offset error that could result in incorrect radiation dose or dose applied to the wrong location.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device software defect that can result in incorrect radiation dose or dose applied to the wrong location, which constitutes a significant injury risk under the rubric for Severe recalls.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK. The software is used as an advanced application on a SOM10 scanner. The recall affects 64 systems distributed nationwide in the United States.

The recall is due to a calibration offset between the central CT image plane and the external RT lasers that has been automatically set to the factory default of 50.00 cm. If this misadjustment is not recognized during the treatment planning process or remains undetected during position verification at the treatment system, such as a linear accelerator, it can potentially result in an incorrect dose or dose applied to the wrong location.

Healthcare facilities using the affected software should contact Siemens Medical Solutions USA, Inc. for further instructions on how to resolve the issue. The source text does not specify a deadline or specific corrective action steps beyond the identification of the defect.

The recalled product

Product: Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Radiation Therapy Software
Hazard: incorrect-dose
mis-targeting
Affected units: 64

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

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