Siemens Biograph mCT S(40)-4R Recalled for Display Freeze Risk
Siemens Medical Solutions is recalling eight Biograph mCT S(40)-4R scanners due to a potential 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 injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling eight units of the Biograph mCT S(40)-4R, System Material Number 10248671. 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 is being conducted because of the possibility of a system display freeze during CT interventional procedures. The affected units are identified by Serial Number 11042.
The recalled devices were distributed in the states of North Carolina and Massachusetts, as well as in Australia, Canada, Switzerland, and Germany. Users of these devices should contact Siemens Medical Solutions USA Inc. for further instructions regarding the recall.
The recalled product
- Product
- Biograph mCT S(40)-4R, System Material Number 10248671. 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: 11042
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.
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