The Recall Desk
HighFDA (Devices)·Z-0960-2015·Announced 2015-01-21

Siemens Symbia CT Systems Recalled for Internal Component Damage

Siemens Medical Solutions is recalling 295 Symbia T and T2 CT systems because a component may come loose and damage the equipment.

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 is classified as FDA Class II, and the source confirms reports of equipment damage. Per the rubric, risk-of-harm products where injury has not yet been reported are rated High (3).

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 295 Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies. The recall covers units distributed worldwide, including the United States and Puerto Rico, as well as numerous international locations.

The recall is being conducted because there are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. The source text does not specify the exact nature of the damage or any resulting patient injuries.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect in the affected systems.

The recalled product

Product
Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.
Affected units
295

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)

  • 1) Symbia T
  • Part Number: 10275007
  • Serial Numbers: 1055
  • 1057
  • 1058
  • 1060
  • 1061
  • 1062
  • 1063
  • 1064
  • 1065
  • 1066
  • 1067
  • 1068
  • 1069
  • 1070
  • 1071
  • 1072
  • 1073
  • 1074

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc.

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