Product Wiki · Recalls · U.S. FDA — Device Enforcement

Angiographic Injector — recall Z-2775-2015

U.S. FDA — Device Enforcement · United States · 2015-08-04 · Class II

As described by U.S. FDA — Device Enforcement: 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2775-2015
Date of alert
2015-08-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bayer Healthcare
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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