Recall Z-1874-2013— Iradimed Corporation

Name: FDA recall Z-1874-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-01

Class I · Terminated

Class I FDA medical device recall by Iradimed Corporation, initiated 2013-07-01, terminated 2015-07-13. It names one FDA 510(k) clearance: K090087. 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..

Recalling firm: Iradimed Corporation
Classification: Class I
Status: Terminated
Initiated: 2013-07-01
Terminated: 2015-07-13
Firm location: Winter Park, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K090087 — MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEMIradimed Corporation·cleared 2009-04-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.