FDA Device recall Z-0745-2019
MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra W…
- FDA Device
- Class II
- terminated
- Published 2019-01-23
On 2019-01-23 the FDA classified a Class II recall of MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra W… by Bayer Medical Care, citing 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 l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0745-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-14 |
| Published | 2019-01-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bayer Medical Care |
| Distribution | US |
Product
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, 115CT, 125CT, 125A, 135A, 135CT, 145, 155A, 165A, 115AS, 115CTS), EOC (700, 700S), EOW 700, EOA 700
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.
Identifiers
| code_info | 3016423 3016423 3016423 59888475 59888475 3016426 3016426 3016426 750001967-2 750001967-2 750001967-2 750001…3016423 3016423 3016423 59888475 59888475 3016426 3016426 3016426 750001967-2 750001967-2 750001967-2 750001967-9 3016424 3016424 3016423 3016423 3016423 3016423 3016423 3016423 3016423 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016424 3016426 3016426 3016427 3016426 3016426 3016426 3016424 3016424 3016423 3016424 3016426 3016423 3016423 3016423 3016423 3016423 3016423 3016424 3016424 3016427 3016423 3016423 3016426 3016426 3016426 3016426 3016423 3016423 3016423 3016423 3016423 3016426 3016426 3016426 3016426 3016424 3016423 3016423 3016424 3016424 3016426 3016426 3016426 3016426 3016423 3016423 3016424 3016423 3016424 3016426 3016423 3016425 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016426 3016423 3016426 3016426 3016426 3016426 3016426 3016426 3016424 3016424 3016424 3016424 3016426 3016426 3016426 3 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0745-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.