—#82077

Product

Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061 Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041166
Affected lot / code info: part 8717741, serial numbers 1326, 1315, 1324, 1330, 1310, 1325, 1336, 1307, 1317, 1331, 1299, 1300, 1301, 1302, 1303, 1304, 1305, 1306, 1308, 1309, 1311, 1312, 1313, 1314, 1316, 1318, 1319, 1320, 1322, 1323, 1327, 1328, 1329, 1332, 1334, 1335, and 1337.

Why it was recalled

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.

Root cause (FDA determination)

Finished device change control

Action the firm took

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.

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2009-04-22
Posted by FDA: 2009-08-04
Terminated: 2010-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82077. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.