Siemens Biograph mCT Flow 40-4R Recalled for Display Freeze Risk
Siemens Medical Solutions is recalling one Biograph mCT Flow 40-4R scanner due to a potential display freeze during CT interventional procedures.
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 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 one unit of the Biograph mCT Flow 40-4R, System Material Number 10529159. The affected unit has Serial Number 11002. These systems 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 for a system display freeze during CT interventional procedures. This defect could impact the operation of the scanner during specific medical interventions.
The affected unit was distributed in the states of North Carolina and Massachusetts, as well as in Australia, Canada, Switzerland, and Germany. Healthcare facilities that possess this specific serial number should contact Siemens Medical Solutions USA Inc. for further instructions on how to address the issue.
The recalled product
- Product
- Biograph mCT Flow 40-4R, System Material Number 10529159. 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
- 1
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: 11002
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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