RecallRadar

FDA Device recall Z-1983-2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems

On 2021-07-07 the FDA classified a Class II recall of Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems by Philips North America, citing 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 pot….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1983-2021
ClassificationClass II
Statusongoing
Initiated2021-05-01
Published2021-07-07
Last updated2026-09-13 11:56 UTC
CompanyPhilips North America
DistributionUS

Product

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore

Reason

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.

Identifiers

code_info
Model/ Serial Number/UDI: N/A 728242 20004 N/A 728242 768007 (01)00884838095168 728242 20013 N/A 728243 75107 N/A…Model/ Serial Number/UDI: N/A 728242 20004 N/A 728242 768007 (01)00884838095168 728242 20013 N/A 728243 75107 N/A 728243 7729 N/A 728243 7786 N/A 728243 7741 N/A 728243 7820 N/A 728243 7892 N/A 728243 75027 N/A 728243 75029 N/A 728243 7941 N/A 728243 75047 N/A 728243 7467 N/A 728243 7831 N/A 728243 7831 N/A 728243 7560 N/A 728243 75067 N/A 728243 7689 N/A 728243 7442 N/A 728243 75111 N/A 728243 7927 N/A 728243 7558 N/A 728243 7769 N/A 728243 7284 N/A 728243 75066 N/A 728243 7905 N/A 728243 7800 N/A 728243 7724 N/A 728243 7946 N/A 728243 7385 N/A 728243 7192 N/A 728243 7211 N/A 728243 7891 N/A 728243 75041 N/A 728243 7269 N/A 728243 7064 N/A 728243 7116 N/A 728243 7214 N/A 728243 7795 N/A 728243 7701 N/A 728243 7810 N/A 728243 7743 N/A 728243 75064 N/A 728243 75120 N/A 728243 750005 N/A 728243 750013 N/A 728244 760014 (01)00884838059450(21)760014 728244 760013 (01)00884838059450(21)760013 728244 76230 N/A 728244 76259 (01)0088483805

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1983-2021%22

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