The Recall Desk
SevereFDA (Devices)·Z-0713-2018·Announced 2018-03-07

Siemens SOMATOM Go.Up CT Table Recall for Potential Instability

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

What this means for you

Illness, injury, or structural failure has been reported. 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 rating (structural defect/significant injury risk).

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling six units of the SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number 11061628. The recall involves specific serial numbers: 108054, 108059, 108062, 108069, 108076, and 108077. These devices were distributed in the United States in the states of Florida, Missouri, New York, and Tennessee.

The recall is being issued because the nuts on the bolts of the table may not have been adequately tightened. This defect has the potential to allow the bolts to loosen, with several bolts potentially loosening at the same time. If this occurs, the table may become unstable.

Healthcare facilities that possess these specific serial numbers should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this recall.

The recalled product

Product
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 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 t
Affected units
6

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 (6)

  • Serial Numbers: 108054
  • 108059
  • 108062
  • 108069
  • 108076
  • 108077

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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