The Recall Desk
HighFDA (Devices)·Z-2248-2018·Announced 2018-06-27

Siemens Biograph mCT Systems Recalled Due to Falling Laser Cover Windows

Siemens Medical Solutions is recalling 405 Biograph mCT systems because laser cover windows may fall off, posing a potential hazard.

What this means for you

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 components) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed harm.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 405 units of Biograph mCT and Biograph mCT Flow systems. These are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners used by health care professionals for diagnostic imaging.

The recall was initiated after the company's supplier reported that some laser cover windows may fall off a limited population of these systems. The affected units were distributed worldwide.

Health care facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. The source text does not specify a consumer action for the general public, as these are professional medical devices.

The recalled product

Product
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: 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
Manufacturer
Siemens Medical Solutions USA, Inc.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
405

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 (16)

  • (a) Biograph mCT S(64)-3R
  • Material Number 10248669
  • Material Number 10248671
  • Material Number 10248672
  • Material Number 10248670
  • Material Number 10248673
  • Material Number 10507786
  • Material Number 10528955
  • Serial Numbers: 11001 (h) Biograph mCT S(40)-3R
  • Material Number 10248668
  • Material Number 10250743
  • Serial Numbers: 1002 (j) Biograph mCT Flow 40-4R
  • Material Number 10529159
  • Serial Numbers: 11001 (k) Biograph mCT-X w/TrueV Upgrade
  • Material Number 10250745
  • Serial Numbers: 1001

Distribution

Distribution scope not specified by the agency.

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