Z-2775-2015Class II

Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW...

Name: Z-2775-2015 Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW...
Creator: Bayer Healthcare
Published: 2015-08-04
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2015-08-04 / Terminated / root cause: software

FDA source

Bayer Healthcare began a recall of Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of... on 2015-08-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2775-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-04
Posted: 2015-09-16
Terminated: 2016-08-17
Recalling firm: Medrad, Inc.
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.
Product code: DXT Injector And Syringe, Angiographic
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2775-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2775-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-16

Product code DXT

K132928Class IIMedrad Mark 7 Arterion Injection System / Syringe, Twist & Go SyringeMedrad, Inc. / Bayer Medical Care, Inc. / cleared 2014-01-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)