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Terminated

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 Recall Z-0617-03 · Posted 2003-03-06

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYX
Date Initiated2003-02-10
Date Terminated2004-04-30
Product Quantity256 units

Reason for Recall

Unintended yoke rotational motion.

Firm 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.

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K850397ORBITOR II COUNTER BALANCE CAMERASiemens Gammasonics, Inc. · 1985-03-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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