Z-0617-03

Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc...

Name: Z-0617-03 Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2003-02-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-02-10 / Terminated

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc., Nuclear Medicine Group, 2501 North Barrington Road... on 2003-02-10. The reason FDA records is "Unintended yoke rotational motion". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0617-03
Status: Terminated
Initiated: 2003-02-10
Posted: 2003-03-06
Terminated: 2004-04-30
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc., Nuclear Medicine Group, 2501 North Barrington Road, Hoffman Estates, IL 60195-5203
Product code: IYX Camera, Scintillation (Gamma)
Reason for recall: Unintended yoke rotational motion.
FDA root cause: Other
Action: Siemens sent Customer Advisory letters dated 2/10/03 to all Integrated Orbiter customers. The accounts were informed of the problem with unexpected camera movement in the opposite direction at the beginning of a SPECT study, and were advised to use the emergency stop at any indication of improper camera movement. The customers were advised that they would be contacted by their Siemens Customer Service Representative to schedule a firmware upgrade that will prevent the occurrence of unintended camera rotation. The upgrade will be done free of charge.
Quantity in commerce: 256 units
Distribution: Nationwide, United Arab Emirates, Argentina, Austria, Azerbaizan,Bangladesh, Belgium, Brazil, Canada, China, Colombia, Cyprus, France, Germany, Great Britain, Greece, Hong Kong, India, Ireland, Italy, Jordan, Japan, Korea, Norway, Pakistan, Romania, Switzerland, Tunisia, Venezuela and the Netherlands.
Product codes and lots: model 35-26-932, serial numbers 102, 1001/1217, 1169A; model 35-44-637, serial numbers 0101/0142, 120A

Product code IYX

K850397Class IOrbitor II Counter Balance CameraSiemens Gammasonics, Inc. / cleared 1985-03-26

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)