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U.S. Department of Health and Human Services

Class 1 Device Recall MRidium 1145 Dose Reduction System (DERS)

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 Class 1 Recall
MRidium 1145 Dose Reduction System (DERS)
see related information
Date Posted August 02, 2013
Recall Status1 Open
Recall Number Z-1874-2013
Recall Event ID 65778
Premarket Notification
510(K) Number
K090087 
Product Classification Pump, Infusion - Product Code FRN
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.
Code Information 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.
Recalling Firm/
Manufacturer
Iradimed Corporation
7457 Aloma Ave
Suite 201
Winter Park, Florida 32792-9172
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 - recallsupport@iradimed.com.
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = IRADIMED CORPORATION
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