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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a risk-of-harm product (medical imaging system) where specific injury or illness has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Navigation, Inc. is recalling 596 O-arm 1000 2nd Edition Imaging Systems, Model Number Bl70000027GERR, due to reported software anomalies. The affected systems are mobile x-ray devices designed for 2D fluoroscopic and 3D imaging, intended for use where physicians benefit from high-resolution imaging of anatomic structures and objects with high x-ray attenuation.
The software anomalies affect several system functionalities, including startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. The recall covers all serial numbers of the affected model. The products were distributed worldwide, including in the United States (specific states listed in the source) and numerous foreign countries.
Medtronic will install software version 3.1.7 on all 2nd edition imaging systems to address the issue. Healthcare facilities and users of these systems should contact Medtronic for further instructions on the software update.
The recalled product
- 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
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Category
- Medical Device — Imaging System
- Affected units
- 596
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers
Distribution
Part of a larger recall action
This product is one of 10 recalled by Medtronic Navigation, Inc.-Littleton under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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