| Class 2 Device Recall Medrad Mark 7 Arterion Injection System | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DXT
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