Agency classClass IIOur severity:Severe FDA (Devices)·Z-0714-2018·Announced 2018-03-07

Siemens CT Table Recalled Due to Potential Bolt Loosening and Instability

Siemens Medical Solutions is recalling SOMATOM Go.Now CT system tables because bolts may loosen, causing the table to become unstable.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device that could lead to instability and potential injury, meeting the criteria for a Severe (Score 4) classification.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling one unit of the SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number 11061618, Serial Number 106115. The recall was initiated because the nuts on the bolts may not have been adequately tightened, creating a potential for the bolts to loosen.

If the bolts loosen, the table may become unstable. The source notes that several bolts may gradually loosen at the same time. This product is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The affected unit was distributed in the United States in the states of Florida, Missouri, New York, and Tennessee. The FDA has classified this recall as Class II. Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall.

The recalled product

Product: SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Equipment
Hazard: structural-defect
instability
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: 106115

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 2 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.

See all 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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