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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Orthoscan, Inc.
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0258-2018
Related Recalls
Ziehm Solo. Digital Mobile C-arm
Orthoscan
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.