Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
Check against the official notice below — it lists the full affected range.
Philips North America LLC is recalling 1,301 Monitor Bracket Assemblies used in Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option systems with Monitor 728333 for Spectral CT equipment. The Monitor Bracket Assembly shaft can experience significant wear that may go unrecognized, potentially causing the bracket to detach from the Suspension Arm. If detachment occurs, the monitor could fall while still attached to cables, creating a serious injury risk to patients, operators, bystanders, or service personnel.
The affected equipment has been distributed worldwide, including throughout the United States and in numerous countries across Europe, Asia, Africa, the Middle East, and the Americas. The source document does not specify what actions affected consumers should take in response to this recall.
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 10016 (01)00884838101111(21)10016 10018 (01)00884838101111(21)10018
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.