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U.S. Department of Health and Human Services

Class 2 Device Recall O2 Imaging System

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  Class 2 Device Recall O2 Imaging System see related information
Date Initiated by Firm July 25, 2023
Date Posted August 24, 2023
Recall Status1 Open3, Classified
Recall Number Z-2449-2023
Recall Event ID 92778
510(K)Number K151000  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product The 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 Contact Christine Steward
978-698-6000
Manufacturer Reason
for Recall		 Ground cable installed incorrectly.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers 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 Commerce 28 units
Distribution Worldwide - 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 Cycle TPLC 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) Database 510(K)s with Product Code = OWB and Original Applicant = MEDTRONIC INC.
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