Bayer Healthcare recalls Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be us…

Recall date

August 4, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2775-2015

FDA classification

Class II

Brand / firm

Bayer Healthcare

Sold / distributed

Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.