Siemens SOMATOM go.All CT Scanner Injector Holder Recall
Siemens Medical Solutions is recalling SOMATOM go.All 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 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the SOMATOM go.All computed tomography (CT) system, model #11061638. The recall involves all serial numbers of this specific model.
The recall was initiated because the injector holder could potentially fall off together with the injector and the storage box. This CT system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
The affected units were distributed nationwide in the following states: FL, KS, WI, NE, MS, OH, TX, NY, LA, IN, IL, OK, MI, GA, NJ, AK, CT, AL, and MD. Healthcare facilities should contact Siemens Medical Solutions for instructions on how to address this issue.
The recalled product
- Product
- SOMATOM go.All; Models #11061638 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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