Z-1874-2013Class I

MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR...

Name: Z-1874-2013 MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR...
Creator: Iradimed Corporation
Published: 2013-07-01
License: https://open.fda.gov/license/

Iradimed Corporation / initiated 2013-07-01 / Terminated / root cause: software

FDA source

Iradimed Corporation began a recall of 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... on 2013-07-01. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1874-2013
Classification: Class I
Status: Terminated
Initiated: 2013-07-01
Posted: 2013-08-02
Terminated: 2015-07-13
Recalling firm: Iradimed Corporation
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.
Product code: FRN Pump, Infusion
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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: The firm, Iradimed Corporation, notified by phone and sent an "URGENT MEDICAL DEVICE RECALL NOTICE" via email dated July 1, 2013 all consignees/customers. The notice described the product, problem and action to be taken. The customers were instructed to identify the MRidium 3860+ MR Infusion Pumps which have the 1145 DERS Library card (AM05) installed. If these are not installed, no further action is required at this time; however, if they are installed-remove the 1145 DERS Library Card from the 3860 Pump using the instructions provided. Product will be reconditioned by installing a software upgrade that corrects this problem. The updated software (version 3.5.1) can be seen during the 3860+ Pump's power on cycle. Should your users have any questions following these instructions, please contact Iradimed Customer Service; 866-677-8022 (toll free) or 407-677-8022 ext. 100 or via e-mail - [email protected]
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1874-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1874-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-02

Product code FRN

K090087Class IIMridium 3860 MRI Infusion Pump/monitoring SystemIradimed Corporation / cleared 2009-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)