—#50151

Product

Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203 USA; part number 08717741

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041166
Affected lot / code info: All systems with pinhole collimators and e.soft software versions 5.5 or earlier: part number 08717741, serial numbers 01006, 01008, 01009, 01019, 01021, 01022, 01024, 01032, 01033, 01034, 01038, 01044, 01045, 01049, 01051, 01052

Why it was recalled

Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.

Root cause (FDA determination)

Other

Action the firm took

Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 1/30/07 to all users of Symbia systems with a pinhole collimator and e.soft software versions 5.5 or earlier. The accounts were informed of the potential for a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage. The customers were advised that a Siemens Customer Service Representative would be sent to their site to upgrade their system software to version syngeo MI Applications 2006A within 30 days. The upgrade will be done free of charge.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution --- including USA states of Alabama, California, Georgia, Indiana, Kentucky, Michigan, Ohio, Pennsylvania, Texas, Virginia and countries of Australia, Bolivia, Canada, China, France, Germany, Hong Kong and Spain.

Timeline

Recall initiated: 2007-01-30
Posted by FDA: 2007-02-23
Terminated: 2007-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50151. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.