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.
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 involves a high-risk medical device with software anomalies affecting critical functions like motion control and image acquisition, posing a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Navigation, Inc. is recalling 596 O-arm 1000 2nd Edition Imaging Systems, Model Number Bl7000002 7230, due to reported software anomalies. The affected systems are mobile x-ray devices designed for 2D fluoroscopic and 3D imaging, intended for use in surgical settings where physicians benefit from high-resolution anatomical information.
The software anomalies affect several system functionalities, including startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and log generation. The recall covers all serial numbers of the 2nd Edition systems. The products were distributed worldwide, including in the United States and numerous foreign countries.
Medtronic Navigation is installing software version 3.1.7 on all affected 2nd Edition imaging systems to resolve the issues. Healthcare facilities and users should contact Medtronic Navigation to schedule the software update.
The recalled product
- 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
- 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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