Siemens SOMATOM Scope Power Recalled for Software Radiation Risk
Siemens is recalling SOMATOM Scope Power units due to a software issue that may cause unnecessary radiation exposure.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (unnecessary radiation exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the SOMATOM Scope Power (Model 10967888) medical device. The recall is being conducted because of a software issue that creates a potential risk of unnecessary radiation exposure.
The affected units are distributed nationwide. The recall covers specific serial numbers listed in the official agency documentation. No specific number of affected units or reported injuries is provided in the source text.
Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software issue and ensure patient safety.
The recalled product
- Product
- SOMATOM Scope Power (Model 10967888)
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · radiation exposure
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
Similar recalls
- HighSiemens SOMATOM Scope Power CT System Recalled for Power Cutout Risk
FDA (Devices) · 2017-01-04
- HighSiemens Recalls SOMATOM Scope CT Systems for Power Cutout Risk
FDA (Devices) · 2017-01-04
- HighSiemens SOMATOM Force CT scanners recalled for radiation exposure risk
FDA (Devices) · 2018-05-23
- HighSiemens SOMATOM Scope Power CT Scanner Recall for Incorrect Dose Calculations
FDA (Devices) · 2018-05-09
- HighSiemens SOMATOM Force CT Systems Recalled for Software Scan Abort Issues
FDA (Devices) · 2019-08-21
- HighSiemens Recalls CT Scanner Software for Radiation Risk
FDA (Devices) · 2018-05-23