Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Brilliance 64 728317/728318 - Ingenuity Flex
Check against the official notice below — it lists the full affected range.
Philips North America is recalling 1,301 Monitor Bracket Assemblies used with continuous CT fluoroscopy ceiling mount arms on Brilliance 64, Brilliance 40, and Ingenuity Flex 72 CT and PET/CT systems. The shaft of the Monitor Bracket Assembly can experience significant wear that may go unnoticed, potentially causing the assembly to detach from the suspension arm. If this occurs, the monitor could fall while still attached to cables, creating a serious injury hazard to patients, operators, bystanders, or service personnel.
The affected devices have been distributed worldwide, including throughout the United States and in numerous countries across Europe, Asia, Africa, the Middle East, and the Americas. The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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, Quantity: 1,301 Monitor Bracket Assemblies total Lot/code info: Model/ Serial Number/UDI: N/A 728235 90040 728235 90191 728235 90192 728235 90061 728235 29090 728235 90111 728235 29042 728235 90165 728235 29082 728235 29152 728235 90054 728235 90087 728235 90122 728235 90142 728235 90104 728235 90075 728235 9237 728235 90110 728235 90084 728235 90208 728235 9047 728235 90125 728235 90171 728235 90212 728235 90056 728235 90227 728235 90164 728235 90051 728235 90035 728231 9367 728231 95709 728231 10625 728231 10379 728231 9900 728231 10630 728231 10755 728231 10758 728231 90094.. 728231 9524 728231 95443 728231 95463 728231 90046 728231 95706 728231 95305 728231 10139 728231 29086 728231 10273 728231 95046 728231 95044 728231 95324 728231 90180 728231 95062 728231 95155 728231 95206 728231 95122 728231 95159 728231 90199 728231 95434 728231 95717 728231 95328 728231 95401 728231 10393 728231 90154 728231 95365 728231 95457 728231 95054 728231 95267 728231 95156 728231 95515 728231 10659 728231 10635 728231 29056 728231 95601 728231 95712 728231 95404 728231 90141 728231 90153 728231 95087 728231 95029 728231 90045 728231 95038 728231 90100 728231 95023 728231 95089 728231 90152 728231 90151 728231 64081 728231 10060 728231 90042 728231 90077 728231 95345 728231 9755 728231 90098 728231 9898 728231 9621 728231 9859 728231 90106 728231 10067 728231 9670 728231 9937 728231 9066 728231 10733 728231 90128 728231 9703 728231 9716 728231 9151 728231 9655 728231 10698 728231 9805 728231 10111 728231 9862 728231 9045 728231 10221 728231 10773 72823
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.