FDA-Device2015-09-23Class II
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.
Bayer Healthcare
Hazard
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.
Sold states
Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.
Affected count
71
Manufactured in
1 Bayer Dr, Indianola, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2775-2015Don't want to check this manually?
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