Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate The Officemate, FSIII and FSIIIc are compact mobile fluorosc

FDA device recall Z-3015-2011 · posted 2011-08-12 · Terminated

Recall details

Recalling firm

Hologic, Inc.

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

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JAA

Quantity affected

540 units

Distribution

Worldwide distribution: USA (nationwide) and countries of: Argentina, Spain, and Viet Nam.

Date initiated

2011-07-21

Date posted

2011-08-12

Date terminated

2012-06-19

Location

Bedford, MA

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