The Recall Desk
HighFDA (Devices)·Z-2934-2020·Announced 2020-09-09

Siemens Symbia S and T Series SPECT Systems Recalled for Detector Motion

Siemens Medical Solutions is recalling 412 Symbia S and T Series SPECT systems due to a defect that may cause unintended slow motion of the detectors.

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 involves a risk-of-harm product where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for potential harm without confirmed fatalities or severe injuries.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 412 units of the Symbia S-Series and Symbia T-Series SPECT systems. These devices are intended to detect or image the distribution of radionuclides in the body or organ using planar, whole body, and tomographic imaging techniques.

The recall is being issued because the systems may experience unintended slow motion of the detectors in specific situations. This defect could pose a potential risk to patients or operators. The affected units were distributed nationwide across the United States, including in Alabama, Alaska, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wisconsin.

Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this issue. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.

The recalled product

Product
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies u
Affected units
412

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)

  • Model:8717741
  • 8717733
  • 10275007
  • 10275008
  • 10275009
  • 10275010 Serial Numbers: 1054
  • 1075
  • 1124
  • 1019
  • 1235
  • 1230
  • 1002
  • 1105
  • 1135
  • 1217
  • 1158
  • 1026
  • 1037
  • 1081
  • 1128

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc.

See all →