Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Siemens Medical So

FDA device recall Z-1677-2009 · posted 2009-08-04 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

Reason for recall

The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan.

Action taken

Siemens sent Urgent Field Correction Recall letters dated 4/22/09 to the affected users of the Symbia S and Symbia T Systems. The accounts were informed of the potential faulty pinion gear which could crack and cause the gantry to spin freely, damaging the system and potentially injuring a patient during a scan. The customers were advised to stop using the system if they hear any abnormal grinding noise from the gantry. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a replacement of the pinion gear free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.

Root cause

Finished device change control

Status

Terminated

Product code

KPS

Quantity affected

38 units

Distribution

Worldwide Distribution -- USA, Australia, Austria, Brazil, Bulgaria, Canada, China, Finland, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Russia, Spain, Taiwan, and

Date initiated

2009-04-22

Date posted

2009-08-04

Date terminated

2010-06-21

Location

Hoffman Estates, IL

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