Recall Z-3015-2011
Hologic, Inc. · initiated July 21, 2011
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)
Codes / lots: 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…
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: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-3015-2011
- Initiated
- July 21, 2011
- Posted by FDA
- August 12, 2011
- Terminated
- June 19, 2012
- Product code
- JAA – System, X-Ray, Fluoroscopic, Image-Intensified
- Quantity
- 540 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Argentina, Spain, and Viet Nam.
- Recalling firm
- Hologic, Inc., Bedford, MA