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.
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 involves a medical device with software anomalies affecting critical functions like motion control and image acquisition, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Medtronic Navigation, Inc. is recalling 596 O-arm 1000 2nd Edition Imaging Systems. The recall is due to reported software anomalies that affect system functionalities including startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation.
The affected systems are mobile x-ray systems designed for 2D fluoroscopic and 3D imaging, intended for use where a physician benefits from 2D and 3D information of anatomic structures. The products were distributed worldwide, including in the United States and numerous foreign countries.
Medtronic will install software version 3.1.7 on all 2nd edition imaging systems to address the reported anomalies. Healthcare facilities should contact Medtronic for instructions on the software update.
The recalled product
- 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
- 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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