The Recall Desk

FDA (Devices) recall action 78784

Orthoscan, Inc. recalled 4 products on 2018-01-17

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2018-01-17
Critical
0
Units
8,048

Why these products were recalled

OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2018-01-17

    OrthoScan Recalls Mobile Mini C-arm Systems Due to Software Defect

    OrthoScan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than visible.

    Product
    Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2018-01-17

    Orthoscan Mobile Mini C-arm System Recalled for Software Defect

    Orthoscan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than is visible to the user.

    Product
    Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2018-01-17

    Orthoscan Mobile Mini C-arm System Recalled for Software Defect

    Orthoscan is recalling Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than is visible to the user.

    Product
    Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2018-01-17

    OrthoScan Recalls Mobile Mini C-arm Systems Due to Software Defect

    OrthoScan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than visible.

    Product
    Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Distribution
    2 states