Z-2775-2015 Class II Terminated
FDA device recall Z-2775-2015 was initiated by Bayer Healthcare on August 4, 2015 and is designated Class II. 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. The recall status is terminated (terminated August 17, 2016). Affected quantity: 71.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2015
- Initiation Date
- August 4, 2015
- Termination Date
- August 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71
Product Description
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 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.
Distribution Pattern
Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.
Code Information
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