FDA Device recall Z-1874-2013
MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System)
- FDA Device
- Class I
- terminated
- Published 2013-08-14
On 2013-08-14 the FDA classified a Class I recall of MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System) by Iradimed, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1874-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-07-01 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Iradimed |
| Distribution | US |
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
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.
Identifiers
| code_info | Part number 1145 Lots: 4501,4510, 4538, 4587, 4596, 4675, 4690, 4705, 4738, 4748, 4960, 4970, 5001, 5065, 5104, 6164, 5…Part number 1145 Lots: 4501,4510, 4538, 4587, 4596, 4675, 4690, 4705, 4738, 4748, 4960, 4970, 5001, 5065, 5104, 6164, 5221, 5240, 5349, 5361, 5517, 5737, 5764, 5881, 6006, 6151, 6170, 6180, 6252, 6470, 6583, 6806, 6881, 6984, and 7213. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1874-2013%22
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