Recall Z-0745-2019 ยท DXT Injector And Syringe, Angiographic
Bayer Medical Care, Inc.
MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S, 85-P, 100-S, 100-P, 70Si, 97Si), OCS TRACK (58-S, 58-P, 80-S, 80-P), OCS WALL (S, P), OCS (115A, 115C
| Date | Dec 14, 2018 |
| Status | Terminated |
| Reason | If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall. |
| Root cause | Device Design |
| Action | Urgent Medical Device Field Corrective Action notification letters were sent to customers on 12/12/18. |
| Quantity | 16656 |
| Distribution | The products were distributed US nationwide. The products were distributed to the following foreign countries: Algeria, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei Darussalam, Canada, Chile, China, Cote D'Ivoire, Cuba, Curacao, Cyprus, Czech Republic, Denmark |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023183 | MEDRAD STELLANT CT INJECTOR SYSTEM Medrad, Inc., Jan 10, 2003 |
| K112086 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE Medrad, Inc., Oct 14, 2011 |
| K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant C Bayer Medical Care, Inc., Aug 17, 2018 |
| K903390 | MEDRAD MARK V-PLUS INJECTOR Medrad, Inc., Sep 26, 1990 |