Z-1676-2009

Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA...

Name: Z-1676-2009 Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2009-04-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-04-22 / Terminated

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061 Indications for... on 2009-04-22. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1676-2009
Status: Terminated
Initiated: 2009-04-22
Posted: 2009-08-04
Terminated: 2010-06-21
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: KPS System, Tomography, Computed, Emission
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.
FDA root cause: Finished device change control
Action: 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.
Quantity in commerce: 37 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 Turkey.
Product codes and lots: 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.

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)