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U.S. Department of Health and Human Services

Class 2 Device Recall Medrad Mark 7 Arterion Injection System

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  Class 2 Device Recall Medrad Mark 7 Arterion Injection System see related information
Date Initiated by Firm August 04, 2015
Date Posted September 16, 2015
Recall Status1 Terminated 3 on August 17, 2016
Recall Number Z-2775-2015
Recall Event ID 71994
510(K)Number K132928  
Product Classification Injector and syringe, angiographic - Product Code DXT
Product Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
Code Information Catalog numbers: ART 700 PEDL, ART 700 TABL, ART 700 OCS, which utilize Software Version SW 005.006_SH.  Affected serial numbers: 20329, 20570, 101148, 20392, 20425, 20427, 30046, 100945, 100186, 21255, 30086, 20025, 101153, 101159, 20714, 100873, 20437, 100033, 100249, 20333, 100511, 101206, 100002, 100890, 101208, 20323, 20914, 20342, 10172, 10074, 20195, 20196, 20850, 20929, 101106, 30020, 30024, 30033, 20252, 10087, 20851, 100009, 100864, 100335, 10095, 20302, 20306, 100013, 20918, 100141, 20158, 100784, 20735, 20422, 101149, 20842, 20018, 101114, 100056, 100075, 20434, 21024, 20311, 20763, 10055, 20786, 20701, 20729, 20040, 100092, 20501
Recalling Firm/
Manufacturer		 Bayer Healthcare
1 Bayer Dr
Indianola PA 15051-9702
For Additional Information Contact Customer Support
412-767-2400
Manufacturer Reason
for Recall		 Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position.
FDA Determined
Cause 2		 Software design
Action Direct accounts were notified by UPS Notification letter dated August 4, 2015 and advised when using the Arterion Injection System to ensure that purges are completed to avoid the injection of air.
Quantity in Commerce 71
Distribution Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = MEDRAD, INC. / BAYER MEDICAL CARE, INC.
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