Recall Z-2224-2009 ยท JAK System, X-Ray, Tomography, Computed
GE Medical Systems, LLC
GE Healthcare CT/e and HiSpeed X/i, families of computed tomography Systems with Gantry. The CT/e and HiSpeed X/i families CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.
| Date | Sep 18, 2009 (initiated Dec 1, 2008) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 7005 units (787 US, 6218 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, ANTIGUA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BENIN, BOLIVIA, BOSNIA & HERZEGOVINIA, BR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021491 | HISPEED DUAL Ge Medical Systems, Inc., May 22, 2002 |
| K944013 | CT PROSPEED FAMILY GE Medical Systems, Feb 7, 1995 |
| K980169 | HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS General Electric Co., Apr 13, 1998 |
| K991716 | HISPEED NX/I CT SCANNER SYSTEM Ge Medical Systems, Inc., Jun 18, 1999 |
| K993645 | CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM Ge Medical Systems, Inc., Dec 21, 1999 |