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U.S. Department of Health and Human Services

Class 2 Device Recall Fluoroscan Mini Carm

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 Class 2 Recall
Fluoroscan Mini Carm
see related information
Date Posted August 12, 2011
Recall Status1 Terminated on June 19, 2012
Recall Number Z-3015-2011
Recall Event ID 59398
Premarket Notification
510(K) Number
K843920 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate The Officemate, FSIII and FSIIIc are compact mobile fluoroscopic C-arm systems specifically designed for x-ray imaging of extremities. The systems are used by trained medical personnel, but at times are used for non medical applications. The functionality of the units is identical for the OfficeMate, FSIII and FSIIIc. Also the construction of the different models is identical. That includes the mounting of the flex arm to the cabinet and the flex arm to the C-arm. The difference between the models resides in the monitors: " Officemate has one small monitor " FSIII has two larger monitors " FSIIIc is an international version of the FSIII (power kit)
Code Information S/N: Office Mate: 02089805 02109804 02109903 02089810 02079802 09971484 05039816 05119832 02-0103-03 02080007 02129812 06971402 02119912 05039824 05129914 05079811 02079901 02059910 02129905 02069932 10971491 02-0104-01 02039805 02049920 02-0103-01 02-1202-03 02109806 09971460 11971502 02-0204-01 02-0304-01 02-0903-01 02059814 03-0602-04 06-0301-01 02109809 12971511 02-1103-01 02119814 02049809 02049803 02-1103-02 06971416 02040004 02-0803-01 02099817 02-0698-01 02070007 02069902 02090002 02039820 02069808 10971496 02-0603-04 02030123 02110014 07971423 12971509 09971463 02019806 09971465 02120201 05010003 05039833 05039834 05079805 05079808 05079809 05079816 05129916 05129917 05129918 05129921 05129922 05129923 05129924 05129930 05129931 05129932 07971435 08971437 08971442 08971444 08971445 08971446 06971401 05079814 09971471 02059914 02110003 09971485 07971419 05010111 05-0101-11 02039925 05079813 02039922 02040009 02109807 05129813 02040106 02039803 02089804 09971462 05129919 07971421 02109812 04971800 02030013 05079807 02109821 02049816 02-0303-02 02100018 02020008 02089913 02019913 05079806 02010218 02039813 09971474 02100008 10971495 05039832 02-0403-01 06971415 02-0404-01 02-0505-01 07971424 05079817 02069810 02119810 02-1202-01 08-9714-38 05039826 05039827 05039830 05039831 05079804 08971441 08971443 02019903 02100005 02129803 02-0603-03 02079815 02079820 02099806 02-1203-01 02050003 02109805 02129904 10971492 02-0603-01 02010007 02-0602-01 02039902 02119801 02040129 02109813 02089807 FSIII: 01129911 12961374 01069909 03971541 06961191 01039907 06961194 03971430 10961328 05961183 01049819 05971828 10961347 07961212 09961318 04971564 01069804 01079818 09971466 02961097 01039819 01109822 10961337 09961322 12961373 05971830 01971409 01961088 06961187 12971518 04961152 03961122 01089814 05961181 12961377 01029801 02961090 05961164 01060013 01099803 10961348 08971452 05109816 01099805 01971388 01971410 12951076 08971455 09971483 04971798 01039812 06961192 01100001 10961339 03961136 08961286 01129811 07971434 06971411 12971515 08961304 08961303 07961211 01971393 11961350 02961109 03961129 01109811 09961321 01089812 01089817 02961108 10961327 09971461 01059810 01029805 01971397 05971823 03971540 01069803 10961349 09961310 07961220 01049810 01029806 01059807 01059806 09971459 12971512 01099802 11951048 02961115 07971429 02961093 08961306 01019810 06971407 08961297 02961099 01961080 11971506 09961325 01059803 01089816 09961319 06971406 01059812 12952941 08961277 12971517 12961372 01049815 12951070 06961166 06961198 02961096 03961141 06961200 09971468 04971543 11971504 07971433 09961312 06961199 01059802 01971399 03971418 03961121 02961104 08961294 08961302 11961348 06971412 01069807 12961371 01069922 09961311 10961334 10961343 02961089 04961163 10961331 01961087 10961338 12961378 03961127 08961279 01029804 01069811 06961184 01971386 01039810 01039811 01059805 06971409 11961359 05971825 01109814 10961329 01089813 08961300 02961112 01059815 01029803 01079819 01119823 01971385 2100014 02961107 02961116 03961132 03961134 3961140 03961144 04971567 05961171 05961176 05961410 05971829 06961204 07961210 08971454 08971457 09961313 11951046 11961355 12951072 12961380 05971826 08961291 05971820 08961290 05961166 01129830 03971539 01109817 10961341 01971382 07971427 01059804 05971821 03961142 01069935 02961101 08971447 02961117 02961103 06961202 03961139 01039806 08961280 08961283 03971419 01060001 01089801 10971489 12951064 04961149 05961168 01049804 05971824 11971503 11951049 03971537 04971797 04971818 08971453 01971387 06961190 01069812 12951073 11971500 12951069 01029807 12971521 10961345 01019807 09961317 06961185 03971428 02971417 03961146 02961091 08961296 01109802 01059813 05971822 05961173 02961114 09971470 04961148 01971411 11961352 11961367 03971429 01039801 08961295 07961221 06961203 04961161 01109808 08961284 03971427 01049808 08971450 12961381 03961118 10961340 05961167 01069802 09971487 06961195 09971486 10961332 10971490 01089803 12951052 04961160 08961299 03961135 05961178 09961314 02961111 12951077 01019804 05961179 02060204 11961358 03971431 01971413 08961293 02971415 12951071 03971422 07961222 06971403 07961209 01039814 04961150 05961180 01039808 01971394 128A4418 2B8A4B5 31CA4C3 03961131 08961287 07971428 01039823 06961186 12971514 03971420 06971404 08961305 01971383 01019801 01049807 01049916 01059811 01069914 01089907 01129802 06961197 01961082 09971479 04961157 03971421 12975752 09961323 09971481 11961353 04961158 01059808 02961094 04971801 03961123 08961278 06971408 01039809 10961335 04971793 01089809 01039836 02961105 03971432 01019803 11971508 01119828 10971498 04961159 08952566 10971494 02961113 04961153 07971430 01049814 11961360 06971410 03961137 01079903 01029802 08961288 03971426 FSIIIC (International): 03020101 03070004 03-0603-05 03079908 03010016 03-0103-01 02030218 03069931 03119901 03079912 03049805 02080201 03030018 03079902 03080015 03070011
Recalling Firm/
Manufacturer
Hologic, Inc.
35 Crosby Dr
Bedford, Massachusetts 01730-1450
Manufacturer Reason
for Recall
The Flex arm connector to C-arm can break and the C-arm that is supported by the flex arm may fall down
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm, Hologic, Inc., sent an "Urgent: Medical Device Recall" letter dated July 25, 2011 via FedEx to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to visually check the the Flex arm/C-arm on their unit for any sign of damage or cracking, if any damage or cracks are observed, remove the unit from service until they receive the retrofit kit; and to complete and return the Confirmation of Notification form via fax to Hologic at 781-280-0662 or mail using the enclosed pre-addressed, pre-paid return envelope. After the customer confirms that they have the unit in their possession, Hologic will expedite the user installable repair kit. The kits will be available starting the first week of August. The kits will also be dispatched via FedEx. Confirmation of installation will be requested for all dispatched kits. Should you have any questions regarding this recall, require further information or assistance with the software installation call Hologic's Help Desk at 1-800-321-4659.
Quantity in Commerce 540 units
Distribution Worldwide distribution: USA (nationwide) and countries of: Argentina, Spain, and Viet Nam.
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 = JAA and Original Applicant = HEALTHMATE, INC.
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