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Philips North America Llc recalls Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT s
Recalled July 7, 2021 · FDA recall Z-1981-2021 · Philips North America
Hazard
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury. · FDA Class II
Units
1,301 Monitor Bracket Assemblies total
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, AE, AR, AT, AU, BD, BE, BR, CH, CL, CN, CO, CU, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GE, GI, GL, GR, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KG, KH, KR, LA, LB, LK, LT, LY, MM, MN, MU, MV, MY, NI, NL, NO, NZ, OM, PA, PF, PH, PK, PL, PS, PT, QA, RE, RU, RW, SA, SE, SG , SI, SK, TH, TN, TR, UZ, VN, XK, YE, ZA, ZW.
Description
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251 - Brilliance 10 728260 - Extended Brilliance Workspace
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →