The Recall Desk
ModerateFDA (Devices)·Z-0993-2017·Announced 2017-01-18

Siemens Biograph mCT Scanners Recalled for Falling Laser Cover Windows

Siemens is recalling 34 Biograph mCT scanners because laser cover windows may fall off, posing a potential hazard to users.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a component falling off without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Medical Solutions USA Inc. is recalling 34 units of the Biograph mCT S(64)-3R scanner, Material Number 10248669. These are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners used by health care professionals for diagnostic imaging and treatment planning.

The recall was initiated because Siemens became aware, through a supplier, that some laser cover windows on the devices may fall off. The affected units were distributed worldwide, including nationwide in the United States and in various international locations.

Health care facilities should contact Siemens Medical Solutions for instructions on how to address the defect. The specific serial numbers for the affected units are listed in the official recall documentation.

The recalled product

Product
Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic in
Manufacturer
Siemens Medical Solutions USA Inc.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
34

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 (20)

  • Serial Numbers: 1006
  • 11025
  • 11015
  • 11021
  • 11012
  • 11016
  • 11019
  • 1003
  • 1004
  • 11010
  • 11014
  • 11032
  • 1005
  • 11027
  • 11017
  • 11022
  • 11033
  • 11020
  • 11011
  • 21036

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 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 11 products in this recall →

Related recalls

Same manufacturer · Siemens Medical Solutions USA Inc.

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Same hazard · falling object

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