Recall Z-0260-2018
Orthoscan, Inc. · initiated August 31, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial Number List: 5E1290 5H0178 5H0125 5E833 5E1164 5F0395 5E730 5E105 5H0126 5E921 5E742 5F0400 5E756 5E0940 5H0130 5F0126 5F0282 5F0412 5E763 5E0943 5H0151 5F0229 5H0273 5F0441 5E841 5E0961 5H0172 5F0230 5E0944 5F0449 5F0232 5E0981 5H0190 5F0387 5E0945 5F0451 5H0291 5E0982 5H0333 5F0445 5E0955 5F0456 5F0177 5E1009 5E0954 5F0453 5E1000 5F0468 5F0242 5E1042 5E1043 5F0457 5E1025 5F0471 5F0295 5E1051 5E1234 5F0465 5E1177 5F0482 5H0265 5E1063 5E1280 5F0610 5E1185 5F0495 5H0292 5E1080 5E908 5H0104 5E1225 5F0497 5E0938 5E1141 5F0158 5H0114 5E1249 5F0517 5E0990 5E1151 5F0408 5E1174 5E1265 5F0533 5E1021 5E1224 5F0519 5E1232 5E1276 5F0537 5E1032 5E1233 5H0272 5E846 5E1279 5F0548 5E1086 5E1266 5H0290 5E1137 5E1288 5F0594 5E1087 5E1269 5E0998 5E1257 5E734 5F0603 5E1105 5E1284 5E1033 5E1176 5E744 5F0621 5E1115 5E1293 5E1035 5E1178 5E772 5F0626 5E1150 5E1315 5E1047 5E1197 5E775 5F0630 5E1261 5E1316 5E1082 5E1303 5E818 5F0631 5E1287 5E739 5E1242 5E769 5E822 5F0632 5E1292 5E743 5E1289 5E794 5E843 5H0109 5E1299 5E761 5E1305 5E919 5E874 5H0116 5E1317 5E765 5E748 5F0188 5E875 5H0133 5E771 5E773 5F0378 5F0206 5E877 5H0137 5E792 5E782 5F0535 5F0207 5E883 5H0138 5E797 5E806 5H0352 5F0215 5E929…
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
FDA-determined cause: Software design
Action taken
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 National Customer Service Team at (866) 949-4346.
Details
- Recall number
- Z-0260-2018
- Initiated
- August 31, 2017
- Terminated
- April 21, 2021
- Product code
- OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile
- 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, Poland, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, UAE, and United Kingdom.
- Recalling firm
- Orthoscan, Inc., Scottsdale, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0258-2018 Class II | Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with…OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices.… | 08/31/2017Terminated |
| Z-0259-2018 Class II | Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with…OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices.… | 08/31/2017Terminated |
| Z-0261-2018 Class II | Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with…OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices.… | 08/31/2017Terminated |