Recall Z-0767-2020— Medtronic Navigation, Inc.-Littleton
Class II · Terminated
Class II FDA medical device recall by Medtronic Navigation, Inc.-Littleton, initiated 2019-11-15, terminated 2023-09-19. It names 2 FDA 510(k) clearances: K173664, K151000. Product: O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000. Reason: Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient..
- Recalling firm
- Medtronic Navigation, Inc.-Littleton
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-15
- Terminated
- 2023-09-19
- Firm location
- Littleton, MA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Reason for recall
Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.