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)
Recall
- Recall Number
- Z-3015-2011
- Event Number
- 59398
- Firm
- Hologic, Inc.
- FEI Number
- 1221300
- Product Code
- JAA
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- July 21, 2011
- Posted
- August 12, 2011
- Terminated
- June 19, 2012
- Address
- 35 Crosby Dr, Bedford, MA, 01730-1450
Description
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)
The Flex arm connector to C-arm can break and the C-arm that is supported by the flex arm may fall down
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.
Worldwide distribution: USA (nationwide) and countries of: Argentina, Spain, and Viet Nam.
540 units