Z-0283-2012

Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed...

Name: Z-0283-2012 Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2011-10-14
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-10-14 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans... on 2011-10-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0283-2012
Status: Terminated
Initiated: 2011-10-14
Posted: 2011-11-23
Terminated: 2012-10-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: 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.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: 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.
Root cause tag: software
FDA root cause: Component change control
Action: Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated October 14, 2011 to all affected customers. The letters informed customers of the acquisition software defect in the energy window position when an isotope is peaked, which could potentially impact image interpretation, and that the AEB firmware version on their imaging system has been changed to a previously released version until acquisition software service pack is available. For questions or assistance they were instructed to contact Siemens Medical Solutions USA, Inc. at (800) 888-7436.
Quantity in commerce: 2 units
Distribution: Florida, Illinois and Texas
Product codes and lots: Symbia S Series systems, serial numbers 1236 and 1555, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12

Product code KPS

K082506Class IISymbia, Version 4.0Siemens Medical Solutions USA, Inc. / cleared 2008-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)