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Terminated

Symbia T6 System; a dual-detector variable angle gamma camera with a six slice CT scanner; Siemens Medical Solutions USA, Inc., Molecular imaging, Hoffman Estates, IL 60192. The system is used to perform CT scans and nuclear imaging studies with the same instrument, obtaining attenuation corrected images and providing registration of anatomical and physiological images within the patient's anatomy. The Symbia T6 System is used for advanced oncology, neurology and cardiology applications.

FDA Recall Z-0189-2009 · Posted 2008-10-27

Recall StatusTerminated
Product CodeKPS
Date Initiated2008-09-29
Date Terminated2009-12-09
Product Quantity11 units

Reason for Recall

The protective plastic cap over the CT gantry power switch on the Line Connection Box may come loose, exposing the energized electrical contacts within the switch, thereby causing an electric hazard.

Firm Action

Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 9/29/08 to all users of the Symbia T6 and Symbia T16 Systems. The accounts were informed of the potential risk that the protective plastic cap over the CT gantry power switch could come loose, causing an electrical hazard. The customers were advised to avoid contact with the gantry power switch until the protective plastic cap has been replaced, and to leave the power switch on at the line connection box and cycle the CT gantry on and off by toggling the CT gantry circuit breaker within the circuit box. They also were advised that a Siemens Customer Service Representative would contact them within 90 days to schedule a corrective update to their Symbia system free of charge. The accounts were requested to complete and return the enclosed mandatory fax-back form to 1-865-218-3019, acknowledging the receipt and understanding of the 9/29/08 letter and providing their Symbia System model number and serial number. Contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 for assistance.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide to the District of Columbia, Florida, Georgia, Illinois, Indiana, Missouri, Ohio, and Texas, and internationally to Australia, Brazil, Canada, Great Britain, India, Italy, Japan, Norway and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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