Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
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 CCT Arms with Monitor models 728306 and Brilliance iCT models 728311 and 728311 SP. The Monitor Bracket Assembly shaft can experience significant wear that may go unnoticed, potentially causing the bracket to detach from the Suspension Arm. If this occurs, the monitor could fall while still attached to cables, posing a serious injury risk to patients, operators, bystanders, or service personnel.
The recalled equipment has been distributed worldwide, including throughout the United States and in numerous countries across Europe, Asia, Africa, the Middle East, and Latin America. Affected units are identified by specific system serial numbers listed in the recall record. The source document does not specify a remedy or what affected consumers should do.
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 System Code System Serial Number Unique Device Identifier (UDI#) 728306 100788 N/A 728306 100857 (01)00884838059474(21)100857 728306 100739 N/A 728306 100394 N/A 728306 100625 N/A 728306 100664 N/A 728306 100764 (01)00884838059474(21)100764 728306 100280 N/A 728306 100782 (01)00884838059474(21)100782 728306 100830 (01)00884838059474(21)100830 728306 100410 N/A 728306 100413 N/A 728306 100788 N/A 728306 100322 N/A 728306 100374 N/A 728306 100327 N/A 728306 100463 N/A 728306 85033 N/A 728306 85104 N/A 728306 85125 (01)00884838059474(21)85125 728306 85095 (01)00884838059474(21)85095 728306 85018 N/A 728306 85013 N/A 728306 100400 N/A 728306 100402 N/A 728306 100405 N/A 728306 100509 N/A 728306 100331 N/A 728306 100375 N/A 728306 100056 N/A 728306 85019 N/A 728306 100657 N/A 728306 100415 N/A 728306 100507 N/A 728306 100450 N/A 728306 100386 N/A 728306 85113 (01)00884838059474(21)85113 728306 100281 N/A 728306 100441 N/A 728306 100346 N/A 728306 100300 N/A 728306 85039 N/A 728306 100348 N/A 728306 100347 N/A 728306 100345 N/A 728306 100490 N/A 728306 100667 N/A 728306 85054 N/A 728306 100335 N/A 728306 100404 N/A 728306 100604 N/A 728306 100408 N/A 728306 100317 N/A 728306 342002 N/A 728306 85219 (01)00884838059474(21)85219 728306 100682 N/A 728306 100313 N/A 728306 100332 N/A 728306 100092 N/A 728306 100163 N/A 728306 100646 N/A 728306 100714 N/A 728306 85031 N/A 728306 100411 N/A 728306 100720 N/A 728306 100610 N/A 728306 100653 N/A 728306 100517 N
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.