Symbia T6 System; a dual-detector variable angle gamma camera with a six slice CT scanner; Siemens Medical Solutions USA

FDA device recall Z-0189-2009 · posted 2008-10-27 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

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.

Action taken

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

Status

Terminated

Product code

KPS

Quantity affected

11 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

Date initiated

2008-09-29

Date posted

2008-10-27

Date terminated

2009-12-09

Location

Hoffman Estates, IL

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