Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
Check against the official notice below — it lists the full affected range.
Philips North America LLC has recalled 1,301 Monitor Bracket Assemblies used in the IQon Spectral CT Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm (Model 728332). The recalled components have been distributed worldwide, including throughout the United States and in numerous countries across North America, Europe, Asia, Africa, and the Middle East. The Monitor Bracket Assembly shaft can experience significant wear that may go unnoticed, potentially causing the bracket to detach from the Suspension Arm.
If the Monitor Bracket Assembly detaches, the monitor could fall while still connected to its cables, creating a serious injury hazard to patients, operators, bystanders, or service personnel. The recall record does not specify a remedy or corrective action that affected consumers should take.
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 728332 860005 N/A 728332 395001 N/A 728332 860043 (01)00884838059542(21)860043 728332 860131 (01)00884838059542(21)860131 728332 860050 (01)00884838059542(21)860050 728332 860122 (01)00884838059542(21)860122 728332 60038 (01)00884838059542(21)60038 728332 860177 N/A 728332 860185 (01)00884838059542(21)860185 728332 860172 (01)00884838059542(21)860172 728332 60051 (01)00884838059542(21)60051 728332 60009 N/A 728332 860098 (01)00884838059542(21)860098 728332 60054 (01)00884838059542(21)60054 728332 860199 (01)00884838059542(21)860199 728332 860123 (01)00884838059542(21)860123 728332 860059 (01)00884838059542(21)860059 728332 860199 N/A 728332 860015 N/A 728332 860014 N/A 728332 860096 (01)00884838059542(21)860096 728332 860029 N/A 728332 860073 (01)00884838059542(21)860073 728332 860058 (01)00884838059542(21)860058 728332 860082 (01)00884838059542(21)860082 728332 860069 (01)00884838059542(21)860069 728332 860216 (01)00884838059542(21)860216 728332 860193 (01)00884838059542(21)860193 728332 860118 (01)00884838059542(21)860118 728332 860024 N/A 728332 860204 (01)00884838059542(21)860204 728332 60066 N/A 728332 860154 N/A 728332 860175 (01)00884838059542(21)860175 728332 860186 (01)00884838059542(21)860186 728332 860038 N/A 728332 860078 (01)00884838059542(21)860078 728332 60042 (01)00884838059542(21)60042 728332 860110 (01)00884838059542(21)860110 728332 860027 (01)00884838059542(21)860027 728332 860071 (01)00884838059542(21)860071 728332 860139 (01
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.