Z-0164-2010

Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment

Name: Z-0164-2010 Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment
Creator: Siemens Medical Solutions USA Inc.
Published: 2009-08-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-08-11 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA Inc. began a recall of Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment on 2009-08-11. The reason FDA records is "In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0164-2010
Status: Terminated
Initiated: 2009-08-11
Posted: 2009-11-10
Terminated: 2009-12-22
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Medical Solutions USA, Inc. issued an "Urgent Field Correction - Recall" notice to consignees by letter dated September 3, 2009 informing them of the problem and that a Siemens service representative will be in contact shortly to service the affected product. For further information, contact Siemens at 1-800-888-7436.
Quantity in commerce: 2 units
Distribution: Worldwide Distribution -- United States (IL and OH), Germany, France and Hong Kong.
Product codes and lots: serial numbers: 1002 and 1003

Product code KPS

K060631Class IIBiograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. / cleared 2006-03-17

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)