FDA Device recall Z-0258-2018

Mobile Mini C-arm system Part # 1000-0001

FDA Device
Class II
terminated
Published 2018-01-17

On 2018-01-17 the FDA classified a Class II recall of Mobile Mini C-arm system Part # 1000-0001 by Orthoscan, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0258-2018
Classification	Class II
Status	terminated
Initiated	2017-08-31
Published	2018-01-17
Last updated	2026-09-13 11:54 UTC
Company	Orthoscan
Distribution	US

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

Identifiers

code_info	Serial Number List: Model # 1000-0001 5A217 5D528 5D566 5D608 5D647 5D682 5C407 5D529 5D567 5D609 5D648 5D683 5C4… 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 5D7

code_info

Serial Number List: Model # 1000-0001 5A217 5D528 5D566 5D608 5D647 5D682 5C407 5D529 5D567 5D609 5D648 5D683 5C4…

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 5D7

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0258-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.