Iradimed Recalls
3 recalls on record · December 5, 2012 to April 5, 2023 · Medical Devices
Recalls by year
12
13
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 5, 2023Medical DevicesFDA
Iradimed Corporation recalls Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
Hazard: Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion.
August 14, 2013Medical DevicesFDA
Iradimed Corporation recalls MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump Sy
Hazard: 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.
December 5, 2012Medical DevicesFDA
Iradimed Corporation recalls The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic nam
Hazard: Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001 because a section of the device does not meet specifications.