Recall Z-2934-2020— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-2934-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-14

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2020-08-14, terminated 2023-05-01. It names one FDA 510(k) clearance: K200474. 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 up to 588keV.. Reason: This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential risk..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-08-14
Terminated: 2023-05-01
Firm location: Hoffman Estates, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K200474 — Symbia 6.7Siemens Medical Solutions USA, Inc.·cleared 2020-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 up to 588keV.

Reason for recall

This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential risk.

Data sourced from openFDA. This site is unofficial and independent of the FDA.