—#104522

Product

Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K082506
Affected lot / code info: Symbia T Series systems, serial numbers 12316, 1236 and 1013, both with syngo MI Applications version VA60A and Foresight Detector AEB firmware version v1.5.9.12

Why it was recalled

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 (FDA determination)

Component change control

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 2501 Barrington Rd, Hoffman Estates, Illinois 60195-2061

Distribution

Distribution pattern: Florida, Illinois and Texas

Timeline

Recall initiated: 2011-10-14
Posted by FDA: 2011-11-23
Terminated: 2012-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104522. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.