Z-0190-2009

Symbia T16 System; a dual-detector variable angle gamma camera with a sixteen slice CT scanner; Siemens...

Name: Z-0190-2009 Symbia T16 System; a dual-detector variable angle gamma camera with a sixteen slice CT scanner; Siemens...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2008-09-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-09-29 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Symbia T16 System; a dual-detector variable angle gamma camera with a sixteen slice CT scanner; Siemens Medical Solutions USA, Inc., Molecular imaging, Hoffman... on 2008-09-29. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0190-2009
Status: Terminated
Initiated: 2008-09-29
Posted: 2008-10-27
Terminated: 2009-12-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Symbia T16 System; a dual-detector variable angle gamma camera with a sixteen 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.
Product code: KPS System, Tomography, Computed, Emission
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 10 units
Distribution: 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.
Product codes and lots: System part number 10275010, serial numbers 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1009, and 1010; CT Subassembly 10165633, serial numbers 69003 through 69012

Product code KPS

K041166Class IISiemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc. / cleared 2004-05-17

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)