FDA Device recall Z-2775-2015

Angiographic Injector

FDA Device
Class II
terminated
Published 2015-09-23

On 2015-09-23 the FDA classified a Class II recall of Angiographic Injector by Bayer Healthcare, citing 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 upr….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2775-2015
Classification	Class II
Status	terminated
Initiated	2015-08-04
Published	2015-09-23
Last updated	2026-09-13 11:53 UTC
Company	Bayer Healthcare
Distribution	US

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.

Reason

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.

Identifiers

code_info	Catalog numbers: ART 700 PEDL, ART 700 TABL, ART 700 OCS, which utilize Software Version SW 005.006_SH. Affected ser… 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

code_info

Catalog numbers: ART 700 PEDL, ART 700 TABL, ART 700 OCS, which utilize Software Version SW 005.006_SH. Affected ser…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2775-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.