GE Healthcare CT/e and HiSpeed X/i, families of computed tomography Systems with Gantry. The CT/e and HiSpeed X/i famili

FDA device recall Z-2224-2009 · 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

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, AN

Date initiated

2008-12-01

Date posted

2009-09-18

Date terminated

2016-01-27

Location

Waukesha, WI

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