Class I — Iradimed Corporation
| Recalling firm | IRADIMED CORPORATION |
|---|---|
| Registered facility | IRADIMED CORPORATION (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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. |
| Product | 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 |
| Distribution | Worldwide distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, and WA; and countries of: Australia, Austria, Denmark, Epsom, France, Germany, London, Netherlands, Saudia Arabia, and United Kingdom. |
| Initiated | 2013-07-01 |
| Classified | 2013-08-02 |
| Terminated | 2015-07-13 |
| Recall number | Z-1874-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Iradimed Corporation (Z-1874-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65778/
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