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FDA (Device enforcement)Recalled 2021-05-01class ii

Philips North America Llc: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT

Is my product affected?

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT

  • UPC 00884838059559

Check against the official notice below — it lists the full affected range.

What happened

Philips North America is recalling 1,301 Monitor Bracket Assemblies used with Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option monitors (Model 882446) that were distributed worldwide, including throughout the United States and 71 other countries. 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 risk to patients, operators, bystanders, or service personnel. The recall record 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.

Hazard

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.

Details from the source

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 882446 900115 (01)00884838059559(21)900115

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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