MRidium 1145 Dose Reduction System — Class I medical device recall Z-1874-2013
Terminated recall by Iradimed Corporation, reported 2013-08-14, distributed nationwide. The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific
| Recall number | Z-1874-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Iradimed Corporation, Winter Park, FL, United States |
| Recall initiated | 2013-07-01 |
| Classified | 2013-08-02 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2015-07-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, DE, DK, FR, GB, NL |
| Quantity | 176 individuals |
| Lot numbers | 4501, 4510, 4538, 4587, 4596, 4675, 4690, 4705, 4738, 4748, 4960, 4970, 5001, 5065, 5104, 5221, 5240, 5349, 5361, 5517, 5737, 5764, 5881, 6006, 6151, 6164, 6170, 6180, 6252, 6470, 6583, 6806, 6881, 6984, 7213 |
| Model numbers | 1145, 4501, 4510, 4538, 4587, 4596, 4675, 4690, 4705, 4738, 4748, 4960, 4970, 5001, 5065, 5104, 5221, 5240, 5349, 5361, 5517, 5737, 5764, 5881, 6006 and 11 more |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1874-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.