Recall Z-3015-2011 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Hologic, Inc.
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 constructi
| Date | Aug 12, 2011 (initiated Jul 21, 2011) |
| Status | Terminated |
| Reason | The Flex arm connector to C-arm can break and the C-arm that is supported by the flex arm may fall down |
| Root cause | 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 custome |
| Quantity | 540 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Argentina, Spain, and Viet Nam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K843920 | FLUOROSCAN/TM BY HEALTHMATE Healthmate, Inc., Feb 7, 1985 |