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U.S. Department of Health and Human Services

Class 2 Device Recall Revolution XR/d

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 Class 2 Recall
Revolution XR/d
see related information
Date Posted September 22, 2009
Recall Status1 Open
Recall Number Z-0003-2009
Recall Event ID 53158
Premarket Notification
510(K) Number
K051967 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.
Code Information SYSTEM 418525XRD 905575XRD 630856QXI 847437GEXRD3 847437XRDCH 605622RAD 850208XRD 217223XRD 269657XRD 415600XRD3 724873XRDL 615342ERXRD 615342RM1 205939SVXRD 716250RAD1 919575FCI2 919575LSCI 724458XRD 850934XRD 303932XRD 303932XRD 760241XRD 256265XR2 256265XR3 256IXR1 251435XRD1 208743LXRDX 318675ACCR1 318675ACCR2 708783R8 602506XRD 724773XRDL 843573WAXRD 713605XRD 562424XRD 954987PED1 713790MMXRD1 281274XRD2 865481FTXRD 630236XRD 949364ER 210646LXRD 781344XRD 567661XRD 630978XRDE185 630978XRDE186 805494XRD 847429ERT 440816XRD1 253952XRD1 314251JDRM4 636947XRDER 205408SVXRD 813654XRD 715393XRD 330841XRD7 330841XRD9 209669XRD 209669XRD 812238UH2 216844PEDR2 910822VAXRD2 205387WDC 503315WOXRD 803776VR1 XQ0068 XK0002 XK0003 XQ0076 XK0005 XK0006 XK0007 XK0001 082407040266 082407160202 0853070321 0850070730 0850070733 0850070734 0850070735 0850070736 0850070731, and 0850070738.
Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of an error in the generator software on the Revolution XR/d configured with HP 8200 PC consoles that reports a mAs reading that is higher than is actually exposed to patients.
FDA Determined
Cause 2
DESIGN: Software Design
Action Consignees were sent a GE Healthcare "Product Safety Notification" letter dated March 7, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology, and Radiologists. The letter listed the Safety Issue, Affected Product, Safety Instructions, and Contact Information.
Quantity in Commerce 83 (63 USA, 20 OUS)
Distribution Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, ID, IL, IN, LA, MA, MI, MO, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA, and WI and countries of Canada, China, Japan, Korea, and Taiwan.
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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