Cl ll Siemens Symbia Series SPECT System

Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 12/15/11
Class ll:

PRODUCT
1) Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient’s anatomy. Symbia S Series systems, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12. Recall # Z-0283-2012;

2) Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System.
Symbia T Series systems, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12. Recall # Z-0284-2012

REASON
Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications version VA60A with Foresight detectors firmware version v1.5.9.12 on the Symbia systems< p>

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, letter dated October 14, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5 units

DISTRIBUTION
FL, IL, TX

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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