Siemens SOMATOM go.All CT Scanner Recall for Falling Injector Holder
Siemens is recalling 10 SOMATOM go.All CT scanners because the injector holder could fall off. The units are distributed in 20 US states.
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 is classified as FDA Class II and 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 10 units of the SOMATOM go.All computed tomography (CT) system, model #11061630. 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 are 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. The specific serial numbers for the recalled units are 117515, 117476, 117529, 117517, 117505, 117495, 117482, 117496, 117533, and 117535.
This recall is classified as Class II by the FDA. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect.
The recalled product
- Product
- SOMATOM go.All; Models #11061630 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
- Affected units
- 10
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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