Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
Check against the official notice below — it lists the full affected range.
Philips North America is recalling 1,301 Monitor Bracket Assemblies used in Continuous CT Fluoroscopy DVI Ceiling Mount systems, including models Ingenuity Core, Ingenuity Core 128, and Ingenuity CT. The Monitor Bracket Assembly shaft can experience significant wear that may go undetected, potentially causing the bracket to detach from the Suspension Arm. If detachment occurs, the monitor could fall while remaining connected to cables, creating a serious injury hazard to patients, operators, bystanders, or service personnel.
The recalled devices have been distributed worldwide across the United States, Canada, Mexico, and numerous other countries. The specific affected units are identified by model numbers 728321, 728323, and 728326/728327 with various lot and serial numbers listed in the recall notice. The source does not specify a remedy or corrective action 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 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT 728321 52051 N/A 728321 52113 (01)00884838059498(21)52113 728321 52105 (01)00884838059498(21)52105 728321 52106 (01)00884838059498(21)52106 728321 333121 N/A 728321 52018 N/A 728321 310113 N/A 728321 310114 N/A 728321 310128 N/A 728321 310162 N/A 728321 333024 N/A 728321 52159 (01)00884838059498(21)52159 728321 52129 N/A 728321 333078 N/A 728321 52079 N/A 728321 52052 N/A 728321 333057 N/A 728321 333059 N/A 728321 941164 N/A 728321 333132 N/A 728321 333146 N/A 728321 30025 N/A 728321 333043 N/A 728321 333150 N/A 728321 333071 N/A 728321 52110 (01)00884838059498(21)52110 728321 333159 (01)00884838059498(21)333159 728321 52020 N/A 728321 310063 N/A 728321 310141 N/A 728321 310133 N/A 728321 52153 (01)00884838059498(21)52153 728321 333151 N/A 728321 333060 N/A 728321 310377 (01)00884838059498(21)310377 728321 333094 N/A 728321 310059 N/A 728321 333135 N/A 728321 333074 N/A 728321 52046 N/A 728321 52046 N/A 728321 52036 N/A 728321 52029 N/A 728321 52037 N/A 728321 52034 N/A 728321 52035 N/A 728321 310385 (01)00884838059498(21)310385 728321 52108 (01)00884838059498(21)52108 728321 333196 (01)00884838059498(21)333196 728321 310119 N/A 728321 52086 (01)00884838059498(21)52086 728321 310036 N/A 728321 333195 (01)00884838059498(21)333195 728321 310157 N/A 728321 333149 N/A 728321 342002 (01)00884838059498(21)342002 728321 333062 N/A 728321 52165 (01)00884838059498(21)52165 72
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.