ClearanceBrief
Recall Z-1932-2019 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile

Medtronic Navigation, Inc.-Littleton

Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM !DOV BI70000027100 BASE OARM Bl70000027100R SYSTEM lOOV RWK Bl70000027100R BASE OARM 8170000027120 SYSTEM 120V 8170000027120 B

DateMay 1, 2019
StatusTerminated
ReasonThe 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full recharge of the potential capacity and results in the inability of the system to take X-rays, open the gantry, and move the system from one place to another, which may affect the ability to continue use within the operating room until the charger board and/or the batteries are replaced
Root causeDevice Design
ActionMedtronic Navigation issued letter May l, 2019 via FedEx Express Overnight delivery identifying the issue, health risk and action to take: provided a visual mitigation card to attach to the Image Acquisition System (IAS) of their affected systems to serve as a visual reminder. " Consignees will be asked to sign and return the consignee response form; acknowledging receipt of this information and confirmation of having attached the visual mitigation card to their affected system. Review and retain Attachment 8 for further guidance . Attachment B provides instructions for inspecting the batte
Quantity832 units
DistributionWorldwide Distribution - US Nationwide Foreign: ALGERIA AUSTRALIA AUSTRIA BAHRAIN BELGIUM BRAZIL BULGARIA CANADA CANADA CHILE CHINA COLOMBIA CROATIA CZECH REPUBLIC DENMARK EGYPT FINLAND FRANCE GERMANY GREECE HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN KOREA KOREA, REPUBLIC OF KUWAIT
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K092564O-ARM IMAGING SYSTEM
Medtronic Navigation, Inc. (Littleton), Jun 17, 2010