The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric

FDA device recall Z-2449-2023 · posted 2023-08-24 · Open, Classified

Recall details

Recalling firm

Medtronic Navigation, Inc.-Littleton

Reason for recall

Ground cable installed incorrectly.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OWB

Quantity affected

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, & V

Date initiated

2023-07-25

Date posted

2023-08-24

Location

Littleton, MA

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