FDA Medical Device Recalls (openFDA)
Bayer Healthcare: 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.
- Recall number
- Z-2775-2015
- Recalling firm
- Bayer Healthcare
- 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.
- Status
- Terminated
- Initiated
- 2015-08-04
- Posted
- 2015-09-16
- Terminated
- 2016-08-17
- 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.
- 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
- 71
- Distribution
- Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K132928"]
- PMA numbers
- not on file
- Product code
- DXT
- Firm FEI
- 2520313
- Firm city
- Indianola
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28