• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Revolution XR/d.

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Revolution XR/d. see related information
Date Posted July 02, 2014
Recall Status1 Terminated on May 06, 2015
Recall Number Z-1989-2014
Recall Event ID 68528
510(K)Number K012389 
Product Classification System, x-ray, stationary - Product Code KPR
Product GE Healthcare, Revolution XR/d.

Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Code Information FMITR170990153 203576XRD
FMITR170990154 409772RS1
FMITR170990160 615896XR2
FMITR170990161 218249XRD1
FMITR170990162 218249XRD2
FMITR170990163 847677DRAD
FMITR170990167 205592XRD2
FMITR170990168 205620SXRD1
FMITR170990169 208734IMXRD
FMITR170990170 210617H103
FMITR170990171 215710ER1
FMITR170990172 217876ER1
FMITR170990173 225765XRD
FMITR170990174 251990XRD
FMITR170990175 281929XRD1
FMITR170990176 301698XRD
FMITR170990177 303695XRD
FMITR170990178 310264XRD
FMITR170990179 312567XRD1
FMITR170990180 312567XRD2
FMITR170990181 314525SARM4
FMITR170990182 314525SARM6
FMITR170990183 314525SARM7
FMITR170990184 323268XRD1
FMITR170990185 323268XRD2
FMITR170990186 336716BCR6
FMITR170990187 336716BCR8
FMITR170990188 360493DR1
FMITR170990189 402463XRD
FMITR170990190 404321XRD2
FMITR170990191 404501XRD
FMITR170990192 404778WC1
FMITR170990193 408236KSXRD1
FMITR170990194 408236KSXRD10
FMITR170990195 408236KSXRD4
FMITR170990196 408236KSXRD5
FMITR170990197 408236KSXRD6
FMITR170990198 408236KSXRD9
FMITR170990199 412777XRD
FMITR170990200 414527XRD
FMITR170990201 414649XRD1
FMITR170990202 415476UCRAD2D
FMITR170990203 419696XRD
FMITR170990204 423224DR1
FMITR170990205 423926DR1
FMITR170990206 479553XRD1
FMITR170990207 479553XRD2
FMITR170990208 504842XRD17
FMITR170990209 512447XRD
FMITR170990211 516674ERXRD
FMITR170990212 518292XRD1
FMITR170990213 520TMCXRDER
FMITR170990214 530HERLONG
FMITR170990215 541322RM1
FMITR170990216 580765XRD
FMITR170990217 601288XRD4
FMITR170990218 609652XRD
FMITR170990219 610954XRD2
FMITR170990220 617726PR6
FMITR170990221 617726XR1Y2
FMITR170990222 617726XR6Y3
FMITR170990223 626359XRD
FMITR170990224 630978XRDE186
FMITR170990225 650497BWXRD1
FMITR170990226 702270XRD
FMITR170990227 706651OPI1
FMITR170990228 706733V1
FMITR170990229 708216XRD1
FMITR170990230 708216XRD3
FMITR170990231 708422XR1
FMITR170990232 708681XRD5
FMITR170990233 713636LBJ2
FMITR170990234 713792ADRC3
FMITR170990235 717627ER1
FMITR170990236 718206XRD1
FMITR170990237 732745XRD
FMITR170990238 757466RM2
FMITR170990239 757827RM4
FMITR170990240 757827XRD3
FMITR170990241 760242R1
FMITR170990242 812858GWRAD
FMITR170990243 812858GWTOMO
FMITR170990244 831625THU2
FMITR170990245 831648XRD1
FMITR170990246 845483XRD
FMITR170990247 847535GLXRD
FMITR170990248 847618ERXRD
FMITR170990249 850862FR2
FMITR170990250 856582XRD
FMITR170990251 860224RM4
FMITR170990252 864255XRD1
FMITR170990253 864560IP1
FMITR170990254 865544OPXRD2
FMITR170990255 865947XRD1
FMITR170990256 865984RAD1
FMITR170990257 908522XRD
FMITR170990258 912350CHEST
FMITR170990259 936321RAD1
FMITR170990260 941766RM1
FMITR170990261 972731RAD2
FMITR170990262 973429XRD
FMITR170990265 E25887
FMITR170990274 281338XD2
FMITR170990277 401729PXRD
FMITR170990278 210292WHR11
FMITR170990279 415600XRD2
FMITR170990280 801587DX3
FMITR170990281 831625THU1
FMITR170990290 610526XRD2
FMITR170990294 412624XQI
FMITR170990295 216363XRI
FMITR170990308 318442XRD1
FMITR170990309 412623XRD1
FMITR170990310 414649XRD2
FMITR170990313 732442ER
FMITR170990314 813654XRD
FMITR170990315 831883VAXRD1
FMITR170990316 865544UT11
FMITR170990318 570253ER1
FMITR170990322 559228VAXRD
FMITR170990324 973579WDR
FMITR170990325 973726WDR
FMITR170990844 801292RM4
FMITR170990919 415600XRD3
FMITR170990926 310825XRD1
FMITR170990927 409772MN3
FMITR170990928 419251XRD
FMITR170990929 443481ED
FMITR170990930 509248VXRD
FMITR170990931 610954LIT
FMITR170990932 925779XRD
FMITR170990933 JMMCXRD1
FMITR170990934 608263DXER
FMITR170990935 765453XRD1
FMITR170990936 865481EDXRD
FMITR170990940 281274XRD2
FMITR170990941 312MCCDEF5K1
FMITR170990942 330729XRD2
FMITR170990943 440816XRD1
FMITR170990944 503216XRD2
FMITR170990945 570547FCIL
FMITR170990946 601984XRD2
FMITR170990947 617414XRD3
FMITR170990948 650696XRD1
FMITR170990949 708364D8K
FMITR170990950 719333RM2
FMITR170990951 719784D50001
FMITR170990952 808433VAXRD
FMITR170990953 814234R
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall
GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.
FDA Determined
Cause 2
Equipment maintenance
Action GE Healthcare sent an Urgent Medical Device Correction letter dated June 4, 2014, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions in regard to this recall the consignees in the United States were advised to call 800-437-1171. For other countries contact your local GE Healthcare Service Representative. For questions regarding this recall call 800-437-1171.
Quantity in Commerce 1053
Distribution Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGRY, ICELAND, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM YEMEN.
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 MEDICAL SYSTEMS, INC.
-
-