Z-0189-2010

Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033. Indended use: X-Ray...

Name: Z-0189-2010 Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033. Indended use: X-Ray...
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-09-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-09-23 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033. Indended use: X-Ray, Fluoroscopic, Image-intensified on 2009-09-23. The reason FDA records is "possible injury to hand/fingers". 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-0189-2010
Status: Terminated
Initiated: 2009-09-23
Posted: 2009-11-12
Terminated: 2010-01-12
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033. Indended use: X-Ray, Fluoroscopic, Image-intensified.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: possible injury to hand/fingers
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Medical Solutions USA, Inc. issued a "Customer Safety Advisory Notice" dated September 11, 2009 to inform customers of the potential hazard to patients when using the Siregraph CF system. For further information, contact Siemens at 1-610-448-4500.
Quantity in commerce: 14 units
Distribution: Nationwide Distribution -- FL, IL, MI, PA and TX.
Product codes and lots: Model Number 4466033, Serial Numbers: 1506, 1528, 1529, 1539, 1544, 1568, 1633, 1821, 1841, 1864, 1877, 2020, 2023, and 2126.

Product code JAA

K960266Class IISiregraph CfSiemens Medical Solutions USA, Inc. / cleared 1996-03-11

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)