FDA (Devices) recall action 81153

Medtronic Navigation, Inc.-Littleton recalled 10 products on 2018-10-31

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2018-10-31
Critical: 0
Units: 5,960

Why these products were recalled

Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–10 of 10

HighFDA (Devices)··2018-10-31
Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies
Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, motion control, and image acquisition.
Product
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm 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 f
Category
Distribution
45 states
HighFDA (Devices)··2018-10-31
Medtronic O-arm 1000 2nd Edition Imaging System Software Recall
Medtronic is recalling O-arm 1000 2nd Edition Imaging Systems due to software anomalies affecting startup, communication, and image acquisition.
Product
O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm 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
Category
Distribution
45 states
HighFDA (Devices)··2018-10-31
Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies
Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, communication, and imaging functions.
Product
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm 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
Category
Distribution
45 states
HighFDA (Devices)··2018-10-31
Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies
Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, motion control, and image acquisition.
Product
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm 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 an
Category
Distribution
45 states
ModerateFDA (Devices)··2018-10-31
Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies
Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.
Product
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm 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 an
Category
Distribution
45 states
HighFDA (Devices)··2018-10-31
Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems for Software Anomalies
Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, communication, and imaging functions.
Product
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100 Product Usage: The O-arm 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 an
Category
Distribution
45 states
HighFDA (Devices)··2018-10-31
Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems for Software Anomalies
Medtronic Navigation is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and image acquisition.
Product
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7230 Product Usage: The O-arm 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 a
Category
Distribution
45 states
HighFDA (Devices)··2018-10-31
Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies
Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.
Product
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm 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
Category
Distribution
45 states
ModerateFDA (Devices)··2018-10-31
Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies
Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, motion control, and image acquisition.
Product
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER Product Usage: The O-arm 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 2
Category
Distribution
45 states
HighFDA (Devices)··2018-10-31
Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies
Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.
Product
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm 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 3
Category
Distribution
45 states