Siemens SOMATOM go.Top CT Scanner Recall for Falling Injector Holder
Siemens is recalling SOMATOM go.Top CT scanners because the injector holder could fall off with the injector and storage box.
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 (falling equipment) 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 the SOMATOM go.Top computed tomography (CT) system, model #11061648. The recall is due to a potential safety hazard where the injector holder could fall off together with the injector and the storage box.
The affected units were distributed nationwide in the United States, specifically in the states of Florida, Kansas, Wisconsin, Nebraska, Mississippi, Ohio, Texas, New York, Louisiana, Indiana, Illinois, Oklahoma, Michigan, Georgia, New Jersey, Alaska, Connecticut, Alabama, and Maryland. The recall applies to all serial numbers of the specified model.
Healthcare facilities and users of these CT systems should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. The product is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
The recalled product
- Product
- SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
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)
- All serial numbers
Distribution
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.
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