Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
MRidium 1145 Dose Reduction System (DERS) drug library kit. (This Recalled by Iradimed Corporation Due to The Dose Error Reduction System (DERS) can indicate...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Iradimed Corporation directly.
Affected Products
MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans.
Quantity: 176 individuals kits
Why Was This Recalled?
The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Iradimed Corporation
Iradimed Corporation has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report