Recall Z-0258-2018— Orthoscan, Inc.
Class II · Terminated
Class II FDA medical device recall by Orthoscan, Inc., initiated 2017-08-31, terminated 2021-04-21. It names one FDA 510(k) clearance: K051754. 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.. 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.
- Recalling firm
- Orthoscan, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-31
- Terminated
- 2021-04-21
- Firm location
- Scottsdale, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.