Recall Z-2775-2015— Bayer Healthcare
Class II · Terminated
Class II FDA medical device recall by Bayer Healthcare, initiated 2015-08-04, terminated 2016-08-17. It names one FDA 510(k) clearance: K132928. 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..
- Recalling firm
- Bayer Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-04
- Terminated
- 2016-08-17
- Firm location
- Indianola, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.