Recall Z-0588-06 ยท KPS System, Tomography, Computed, Emission
General Electric Med Systems LLC
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.
| Date | Jun 2, 2006 (initiated Jan 26, 2006) |
| Status | Terminated |
| Reason | The LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system. |
| Root cause | Other |
| 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. |
| Quantity | 74 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042257 | DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION General Electric Co., Sep 8, 2004 |