Siemens Biograph mCT Scanners Recalled for Potential Display Freeze
Siemens Medical Solutions is recalling eight Biograph mCT S(64)-4R scanners due to a risk of system display freeze during CT interventional procedures.
What this means for you
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 product (medical device) where a functional failure could impact patient safety, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling eight units of the Biograph mCT S(64)-4R system, identified by System Material Number 10248672 and Serial Number 11021. These devices are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners used to provide registration and fusion of high-resolution physiologic and anatomic information.
The recall was initiated because of a possibility for the system display to freeze during CT interventional procedures. The affected units were distributed in the United States (North Carolina and Massachusetts) and internationally in Australia, Canada, Switzerland, and Germany.
Healthcare facilities and users of these specific scanners should contact Siemens Medical Solutions USA Inc. for further instructions on how to address the potential display freeze issue.
The recalled product
- Product
- Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 8
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 (1)
- Serial Number: 11021
Distribution
Part of a larger recall action
This product is one of 5 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 5 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA Inc.
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · system failure
See all →- HighDxI 9000 Access Immunoassay Analyzer calibration system error recall
FDA (Devices) · 2025-07-02
- HighXhibit Telemetry Receiver may shut down, causing temporary loss of patient monitoring
FDA (Devices) · 2025-01-15
- HighBD Pyxis MedStation 4000 Medication Cabinet Fire Risk Recall
FDA (Devices) · 2024-06-05
- HighPhilips Allura Xper X-ray systems disk bay component may malfunction
FDA (Devices) · 2024-02-28
- HighSyringe Pump Force Sensor Drift May Cause Detection Delays or False Alarms
FDA (Devices) · 2023-10-18