Medtronic O-arm 1000 X-ray System Software Update Recall
Medtronic is recalling 253 O-arm 1000 mobile X-ray systems to implement a software update that resolves multiple operational and imaging defects.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and addresses software defects that affect system operation and imaging reliability. No injuries, illnesses, or deaths are reported in the source text, and the hazard is operational rather than a direct physical injury risk.
Plain-English summary
Medtronic Navigation, Inc. is recalling 253 units of the O-arm 1000 mobile image-intensified fluoroscopic x-ray system. The affected units were distributed worldwide, including across the United States and in numerous international markets. The recall involves specific models and serial numbers identified in the agency's structured data.
The recall is being conducted to implement Software Update 3.2.1, which addresses several identified issues. These issues include the inability to power the system after shutdown, the system remaining in standalone mode, image reconstruction errors, system and pendant bootup problems, dose display and reporting errors, gantry motion issues, network communication failures, system shutdown problems, and early termination of 3D spin operations.
Healthcare facilities and users of the O-arm 1000 system should contact Medtronic Navigation, Inc. to schedule the installation of the software update. The update is necessary to restore proper system functionality and ensure reliable operation of the imaging equipment.
The recalled product
- Product
- O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM…
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Affected units
- 253
Distribution
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