—#26010

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

FDA product code: IYX — Camera, Scintillation (Gamma)
Device class: Class 1
Medical specialty: Radiology
510(k) numbers: K850397
Affected lot / code info: model 35-26-932, serial numbers 102, 1001/1217, 1169A; model 35-44-637, serial numbers 0101/0142, 120A

Why it was recalled

Unintended yoke rotational motion.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 2501 N. Barrington Road, Hoffman Estates, Illinois 60195-5203

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2003-02-10
Posted by FDA: 2003-03-06
Terminated: 2004-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #26010. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.