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Terminated

c.cam Gamma Camera, Model No: 9VIR1200; Tomography System (Emission Computed); Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203; Made in Denmark

FDA Recall Z-0304-2008 · Posted 2007-12-19

Recall StatusTerminated
Product CodeKPS
Date Initiated2007-09-17
Date Terminated2009-01-09
Product Quantity486 units

Reason for Recall

Unintended Motion: A hardware fault in the c.cam system can cause the system to experience unintended motion, thereby causing a collision hazard.

Firm Action

Urgent Field Correction Recall letters dated 9/11/07, on Siemens letter head were sent to the end users via U.S. certified mail, informing them of the potential risk of unintended motion of the detector head resulting in a collision hazard. The end users were warned not to press any of the detection motion buttons while simultaneously holding the collision over ride button on the c.cam hand controller, and were provided steps to take if the system stops during an acquisition and displays the Collision Error message. They were told that a Siemens service representative will contact them within 90 days to schedule the repair of the c.cam at no cost to the end user. Any questions regarding the Important Safety Notice were directed to their service representative or Siemens office at: 1-800-888-7436 (USA).

Root Cause

Software design

Distribution Pattern

Worldwide: USA including Puerto Rico and Brazil, Canada, France, Germany, Great Britain, Israel, The Netherlands, and Portugal.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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