The Recall Desk
HighFDA (Devices)·Z-0912-2015·Announced 2015-01-14

Siemens Symbia T Series SPECT/CT Systems Recalled for Detector Motion

Siemens Medical Solutions USA is recalling 1,330 Symbia T series SPECT/CT systems worldwide due to reports of unintended radial detector motion that may cause patient compression injuries.

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 (potential patient compression injuries) where specific injury counts are not reported, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 1,330 units of the Siemens Symbia T series SPECT/CT systems. The affected systems are distributed worldwide, including in the United States and numerous international markets. The recall involves specific product numbers and serial numbers for the Symbia T, Symbia T2, Symbia T6, Symbia T16, and Symbia-T Series (SPECT/CT) models.

The recall was initiated after Siemens received reports of unintended radial motion of the detectors. According to the source text, this unintended motion, should it occur, may cause patient compression-related injuries. The systems are intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging, and restaging of lesions, tumors, disease, and organ function.

Health care facilities using these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the defect. The source text does not specify a particular date for the recall or a specific number of reported injuries, only that reports of the motion have been received.

The recalled product

Product
The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limit
Affected units
1,330

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: Product Number: 10275007
  • Serial Numbers: 1003
  • 1005
  • 1006
  • 1007
  • 1008
  • 1009
  • 1010
  • 1011
  • 1012
  • 1013
  • 1014
  • 1015
  • 1016
  • 1017
  • 1018
  • 1019
  • 1020
  • 1021
  • 1022

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc.

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