Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/MA/MN, S9116LA/MA. The system combines the high performance Lightspeed Plus CT with high performance PET that is optimized for routine 2D and 3D oncology, cardiology and neurology clinical studies.
FDA Recall Z-0588-06 · Posted 2006-06-02
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Recalling FirmGeneral Electric Med Systems LLC
Recall StatusTerminated
Product CodeKPS
Date Initiated2006-01-26
Date Terminated2006-12-27
Product Quantity74
Reason for Recall
The LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system.
Firm Action
All affected customers are being sent an 'Important Radiation Safety Notification' letter dated November 10, 2005, that identifies affected units, the associated potential hazards, and the planned modification. A Copy of the Technical Reference Manual will be included with the customer letter.
Root Cause
Other
Distribution Pattern
Nationwide, Worldwide. AL, CA, CT, FL, IN, MA, MD, MN, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, WA, Puerto Rico. OUS to include: Austria, Brazil, Canada, China, Columbia, Egypt, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Portugal, United Kingdom, Venezuela
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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