O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000

FDA device recall Z-0767-2020 · posted 2019-12-31 · Terminated

Recall details

Recalling firm

Medtronic Navigation, Inc.-Littleton

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.

Action taken

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 internal motor drive belt over extended number of uses, image rotation may occur relative to patient positioning data. Inaccuracy may occur when the O-arm registration information is transferred to an Image-Guided Surgery System to be used in navigation, utilizing the rotated images. Navigational inaccuracies are inherent in the use of any Image-Guided Surgery System utilizing an O-armTM O2 Imaging System, but the potential for inaccuracy may be higher if image rotation occurs in an affected system. This letter provides awareness of this issue and reinforces existing instructions within the O-arm" O2 Imaging System User Manual (IFU) that allow for identification of the issue if it occurs. This issue does not involve the O-arm 1000 Imaging Systems. Issue Background and Summary: The O-arm" O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging 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. Medtronic has determined that if the gantry tractor motor drive belt loosens over extended number of uses, it can 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

Root cause

Device Design

Status

Terminated

Product code

OWB

Quantity affected

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

Date initiated

2019-11-15

Date posted

2019-12-31

Date terminated

2023-09-19

Location

Littleton, MA

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