FDA-Device2019-01-23Class II
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
Bayer Medical Care, Inc.
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.
Sold states
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.
Affected count
16656
Manufactured in
1 Bayer Dr, Indianola, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0745-2019Don't want to check this manually?
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