Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall O2 Imaging System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall O2 Imaging Systemsee related information
Date Initiated by FirmJuly 25, 2023
Date PostedAugust 24, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2449-2023
Recall Event ID 92778
510(K)NumberK151000 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductThe O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
Code Information Model No. BI70002000; UDI-DI: 00763000074128, 00763000081041, 00763000355555, 00763000496784, 00763000542801, 00763000616434, 00763000616526, 00763000616564; Serial No. C2786, C2841, C2781, C2624, C2659, C2660, C2665, C2672, C2708, C2723, C2735, C2760, C2774, C2775, C2779, C2798, C2814, C2823, C2873, C2918, C2968, C3290, C3363, C3188, C3322, C3387, C3404, and C3418.
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.-Littleton
300 Foster St
Littleton MA 01460-2017
For Additional Information ContactChristine Steward
978-698-6000
Manufacturer Reason
for Recall		Ground cable installed incorrectly.
FDA Determined
Cause 2		Under Investigation by firm
ActionCustomers were sent recall notification via UPS 2-day delivery on 7/25/2023. The recall notification informs consignees they may continue to use the device per facility protocol; there is no risk to the patient or user when system panels remain intact. Consignees are to inform all personnel in all care environments in with the recalled device is used about the provided Medical Device Correction Notice and to post copies of the notification in a prominent location to maintain awareness until the issue is resolved by a Medtronic Field Service Engineer. Consignees are to complete and return the provided customer confirmation form via email to neuro.quality@medtronic.com. If consignees are aware of any incidents related to this recall, they are to contact Technical Support immediately by phone at 1-888-826-5603 or by mail at rs.navtechsupport@medtronic.com. Medtronic will schedule a service visit to correct this issue but if consignees have any questions regarding this issue in the interim, contact Technical Services for help at 1-800-595-9709 (US) or 1-700-890-3160 (OUS) and reference FA1351.
Quantity in Commerce28 units
DistributionWorldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KY, MI, MO, NC, NV, OH, TN, UT, VA, & WA. The countries of Canada, Ireland, Poland, Russian Federation, Switzerland, & Viet Nam.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
-
-