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U.S. Department of Health and Human Services

Class 2 Device Recall REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS

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 Class 2 Recall
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
see related information
Date Posted February 21, 2012
Recall Status1 Terminated on August 02, 2012
Recall Number Z-1065-2012
Recall Event ID 60126
Premarket Notification
510(K) Number
K051967 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
GE Healthcare has become aware of a potential issue associated with the hand grip that is clamped to the table top of your Revolution XRD X-ray systems that may impact patient safety. The hand grip accessory that is clamped to the table top may not be properly adjusted and can dislodge during use. Should this happen during patient loading or unloading, patient injury could occur.
FDA Determined
Cause 2
DESIGN: Device Design
Action GE Healthcare sent an Urgent Medical Device Correction letter dated October 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to remove the hand grip accessory from use until the product is corrected and to take extra precautions when loading or unloading patients from the table while the hand grips are not in use. A GE Healthcare service representative would contact the consignee to arrange for the correction. For questions regarding this recall call 262-513-4122.
Quantity in Commerce 772
Distribution Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WY, WI and the countries of VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SPAIN, SLOVENIA, SAUDI ARABIA, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, NETHERLANDS, MALTA, KUWAIT, JORDAN, JAPAN, ITALY, ISRAEL, HONG KONG, GERMANY, FRANCE, ECUADOR, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, and AUSTRALIA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = GE HEALTHCARE
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