Home / Recalls / Medtronic Navigation, Inc.-Littleton / Z-2026-2024

Z-2026-2024 Class II Ongoing

Recalled by Medtronic Navigation, Inc.-Littleton — Littleton, MA

Recall Details

Product Type
Devices
Report Date
June 12, 2024
Initiation Date
April 26, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 units

Product Description

O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000

Reason for Recall

Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, MN, PR, TX, WI and the countries of Bangladesh, Canada, Costa Rica, India, Mexico, Panama, Philippines.

Code Information

GTIN: 00643169639683 00763000616441 00763000616465 00763000616526 00763000616533 00763000616564 00763000616571 Serial Numbers: C3578 C3421 C3606 C3645 C3641 C3589 C3604 C3537 C3551 C1595 C1437 C3469 C3635 C3626 C3389 C3647 C3407 C3713 C3607 C1629

Other recalls by Medtronic Navigation, Inc.-Littleton

  • Z-2449-2023 Class II — The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopi (July 25, 2023)
  • Z-0767-2020 Class II — O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 (November 15, 2019)
  • Z-1932-2019 Class II — Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX ( (May 1, 2019)
  • Z-0404-2019 Class II — Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray s (September 17, 2018)
  • Z-0273-2019 Class II — O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Mode (August 30, 2018)
  • Z-0272-2019 Class II — O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Mo (August 30, 2018)
  • Z-0278-2019 Class II — O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, (August 30, 2018)
  • Z-0280-2019 Class II — O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFU (August 30, 2018)
  • Z-0276-2019 Class II — O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V (August 30, 2018)
  • Z-0277-2019 Class II — O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Mode (August 30, 2018)