Recall Z-0261-2018 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Orthoscan, Inc.
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.
| Date | Aug 31, 2017 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| Action | Orthoscan sent an Urgent Recall Notice, dated August 30, 2017, to customers, informing them of the issue and how to address it. Customers are to use the attached list of serial numbers to determine if their device is affected. Customers may continue to use their affected device with caution until the on-site correction has been made. Users should avoid non-conforming workflows by taking the measures outlined in the letter. The firm will contact customers to arrange implementation of the corrective action at no cost to the customer. If there are further questions or concerns, please call |
| Quantity | 2012 total |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and Hawaii and to the countries of : Australia, Austria, Belgium, Canada, Dominican Republic, Estonia , Finland, France, Germany, Hanover, Hong Kong, Israel, Italy, Japan, Jonesboro, Korea, Malaysia. Netherland, New Zealand, Norway, Pol |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133174 | ORTHOSCAN FD MINI C-ARM Orthoscan, Inc., Mar 28, 2014 |