MAVIG Portegra or Portegra2 Overhead Counterpoise System — Class II medical device recall Z-0745-2019
Terminated recall by Bayer Medical Care, Inc., reported 2019-01-23, distributed nationwide. If the head mount knob is not properly tightened and the operator directly uses the injector head to move the
| Recall number | Z-0745-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Medical Care, Inc., Indianola, PA, United States |
| Recall initiated | 2018-12-14 |
| Classified | 2019-01-15 |
| Reported by FDA | 2019-01-23 |
| Terminated | 2020-06-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BM, BR, BS, CA, CH, CL, CN, CW, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GH, HK, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KR, KW, LB, LT, LU, LV, MA, MX, MY, NL, NO, NZ, OM, PA, PH, PK, PL, PT, RS, SA, SE, SG, SK, TH, TN, TR, TT, TW, UY, VE, VN, ZA |
| Quantity | 16,656 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0745-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.