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U.S. Department of Health and Human Services

Class 2 Device Recall OrthoScan HD (10000001)

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  Class 2 Device Recall OrthoScan HD (10000001) see related information
Date Initiated by Firm August 31, 2017
Create Date January 09, 2018
Recall Status1 Terminated 3 on April 21, 2021
Recall Number Z-0258-2018
Recall Event ID 78784
510(K)Number K051754  
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
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.
Code Information Serial Number List:  Model # 1000-0001 5A217 5D528 5D566 5D608 5D647 5D682 5C407 5D529 5D567 5D609 5D648 5D683 5C417 5D530 5D568 5D610 5D649 5D684 5C423 5D531 5D569 5D611 5D650 5D685 5C427 5D532 5D570 5D612 5D651 5D686 5C428 5D533 5D571 5D613 5D652 5D687 5D501 5D534 5D572 5D614 5D653 5D690 5D503 5D535 5D573 5D615 5D654 5D694 5D504 5D536 5D574 5D616 5D655 5D695 5D505 5D537 5D575 5D620 5D656 5D696 5D506 5D538 5D576 5D621 5D657 5D697 5D507 5D539 5D577 5D622 5D658 5D698 5D508 5D540 5D578 5D623 5D659 5D702 5D509 5D541 5D582 5D626 5D660 5D703 5D510 5D542 5D587 5D627 5D661 5D704 5D512 5D543 5D588 5D628 5D662 5D705 5D513 5D544 5D589 5D629 5D663 5D706 5D514 5D545 5D591 5D630 5D665 5D708 5D515 5D546 5D592 5D631 5D666 5D709 5D516 5D547 5D593 5D632 5D667 5D710 5D517 5D548 5D594 5D633 5D668 5D712 5D518 5D549 5D595 5D634 5D669 5D714 5D519 5D550 5D596 5D635 5D670 5D715 5D520 5D552 5D597 5D636 5D671 5D716 5D521 5D554 5D598 5D637 5D673 5D717 5D522 5D555 5D599 5D638 5D674 5D720 5D523 5D556 5D600 5D639 5D675 5D722 5D524 5D562 5D604 5D640 5D676 5D723 5D525 5D563 5D605 5D641 5D677 5D725 5D526 5D564 5D606 5D643 5D679 5D726 5D527 5D565 5D607 5D646 5D680 5D727 5A201 5A220 5B316 5B324 5C407 5C418 5A202 5B303 5B317 5B326 5C408 5C420 5A203 5B307 5B318 5C401 5C409 5C424 5A204 5B309 5B319 5C402 5C411 5C427 5A210 5B313 5B320 5C403 5C413 5C428 5A217 5B314 5B322 5C405 5C414 5C429 5A218 5B315 5B323 5C406 5C415 5C430  
Recalling Firm/
Manufacturer		 Orthoscan, Inc.
8212 E Evans Rd
Scottsdale AZ 85260-3670
For Additional Information Contact National Customer Service
866-949-4346
Manufacturer 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 2		 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 National Customer Service Team at (866) 949-4346.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OXO and Original Applicant = ORTHOSCAN, INC.
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