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Terminated

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.

FDA Recall Z-2775-2015 · Posted 2015-09-16

Recalling FirmBayer Healthcare
Recall StatusTerminated
Product CodeDXT
Date Initiated2015-08-04
Date Terminated2016-08-17
Product Quantity71

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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