Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/M
FDA device recall Z-0588-06 · posted 2006-06-02 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems LLC
- Reason for recall
- The LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system.
- Action taken
- 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
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 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,
- Date initiated
- 2006-01-26
- Date posted
- 2006-06-02
- Date terminated
- 2006-12-27
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION (K042257) | General Electric Co. | 2004-09-08 |