Recall Z-0767-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Medtronic Navigation, Inc.-Littleton
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
| Date | Dec 31, 2019 (initiated Nov 15, 2019) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | On November 15, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: MEDICAL DEVICE CORRECTION O-arm" O2 Imaging System Dear Healthcare Professional: Medtronic has determined through internal testing that there is a potential for navigational inaccuracy when utilizing the O-armTM O2 Imaging Systems auto-registration feature, when used in conjunction with an Image-Guided Surgery System for a specific set of O-armTM O2 Imaging System serial numbers. A list of potentially affected systems is provided in Table 1 of this letter. Due to loosening of an inte |
| Quantity | 90 |
| Distribution | US: AR CA CO CT FL ID IL IN KS KY MI MN MO NC ND NE NY OH OR PA SC SD TX VA WA WI WV OUS: AUSTRALIA CANADA CHINA FRANCE GERMANY INDIA ITALY JAPAN LEBANON NETHERLANDS ROMANIA SAUDI ARABIA SPAIN SWEDEN SWITZERLAND UNITED KINGDOM |
| FDA record | Open on fda.gov |