Recall Z-2775-2015 ยท DXT Injector And Syringe, Angiographic
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.
| Date | Sep 16, 2015 (initiated Aug 4, 2015) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132928 | MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE Medrad, Inc. / Bayer Medical Care, Inc., Jan 23, 2014 |