Sytec 6000, Sytec 8000, and Lemage/ProSeed/ProSpeed families. The CT/e and HiSpeed X/i families CT Scanner Systems are i
FDA device recall Z-2225-2009 · posted 2009-09-18 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- During internal testing, GE Healthcare has recently determined that the collimator used on our CT/e and HiSpeed X/i families of Computed Tomography systems does not comply with the specific requirements in United States Title 21 of the Code of Federal Regulations, and IEC 60601-1-3, related to leakage radiation from the diagnostic source assembly, which includes the collimator. The excess leak
- Action taken
- GE Healthcare issued an "Important - Electronic Product Radiation Warning" to affected customers. GE Healthcare field service representative will perform a field corrective action on all affected units. All potential users of the device should be made aware of the notification and the information contained. For further information, contact GE Healthcare at 1-800-437-1171 (US) or by contacting your local GE Healthcare service manager.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 643 units ( 136 US; 507 OUS)
- Distribution
- Worldwide Distribution -- UNITED STATES (AL, AZ, AR, CA, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MA, MI, LMN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, PA, PR,SC, SD, TN, TX, VA, WA, WV and WI), ALGERIA, AN
- Date initiated
- 2008-12-01
- Date posted
- 2009-09-18
- Date terminated
- 2016-01-27
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM (K921192) | GE Medical Systems | 1992-10-20 |
| CT SYTEC 8000 (K913485) | General Electric Co. | 1992-01-23 |