Bayer Medical Care, Inc. recalls MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection

Recalled January 23, 2019 · FDA recall Z-0745-2019 · Bayer Medical Care

Hazard

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. · FDA Class II

Units

16656

Sold at

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, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Greenland, Guam, Vatican City State, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mayotte, Mexico, Monaco, Mongolia, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Philippines, Poland, Portugal, Reunion, Russian Federation, Saint Pierre and Miquelon, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey UAE, UK, Uruguay, Venezuela, Vietnam.

Description

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.

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

Manufacturer(s)

Bayer Medical Care, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →