Recall Z-1874-2013 ยท FRN Pump, Infusion
Iradimed Corporation
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.
| Date | Aug 2, 2013 (initiated Jul 1, 2013) |
| Status | Terminated |
| 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. |
| 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 softw |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090087 | MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM Iradimed Corporation, Apr 7, 2009 |