FDA (Devices) recall action 87974

Philips North America Llc recalled 12 products on 2021-07-07

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products: 12
Announced: 2021-07-07
Critical: 0
Units: 14,311

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–12 of 12

HighFDA (Devices)··2021-07-07
CT Monitor Bracket Assembly Recalled Due to Shaft Wear and Detachment Risk
Philips North America is recalling CT system monitor bracket assemblies due to shaft wear that could cause the bracket to detach from the suspension arm, potentially allowing the monitor to fall and cause serious injury.
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
Category
Distribution
10 states
HighFDA (Devices)··2021-07-07
Philips CT Monitor Bracket Assemblies Recalled for Detachment Risk
Philips has recalled 1,301 Monitor Bracket Assemblies for CT systems worldwide due to shaft wear that could cause monitors to detach and fall, potentially injuring patients, operators, or service personnel.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
Category
Distribution
10 states
HighFDA (Devices)··2021-07-07
Monitor Bracket Assembly Fall Hazard Recall Affects Multiple CT Systems
Philips is recalling 1,301 monitor bracket assemblies used with CT systems due to shaft wear that could cause monitors to fall, potentially injuring patients, operators, bystanders, or service personnel.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Brilliance 64 728317/728318 - Ingenuity Flex
Category
Distribution
10 states
HighFDA (Devices)··2021-07-07
Philips Continuous CT Fluoroscopy Monitor Bracket Assembly Fall Risk
Philips is recalling 1,301 Monitor Bracket Assemblies due to shaft wear that could cause the assembly to detach from the ceiling suspension arm. This could result in the monitor falling and causing serious injury to patients, operators, bystanders, or service personnel.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
Category
Distribution
10 states
HighFDA (Devices)··2021-07-07
Philips CT Monitor Bracket Assembly May Detach and Fall
Philips is recalling 1,301 monitor bracket assemblies for CT imaging systems due to shaft wear that could cause detachment and fall of the monitor. This could result in serious injury to patients, operators, and staff.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
Category
Distribution
10 states
HighFDA (Devices)··2021-07-07
Monitor Bracket Assembly Shaft Wear Risk in Philips CT Fluoroscopy Systems
Philips CT fluoroscopy monitor brackets may detach from suspension arms due to unrecognized shaft wear, risking the monitor falling and causing serious injury to patients, operators, or bystanders.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
Category
Distribution
10 states
HighFDA (Devices)··2021-07-07
Philips CT Monitor Bracket Assembly risks ceiling fall hazard
Philips is recalling 1,301 Monitor Bracket Assemblies used in CT and PET/CT imaging systems worldwide due to potential shaft wear that could cause the monitor to detach from the ceiling mount and fall, posing injury risk.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201
Category
Distribution
10 states
HighFDA (Devices)··2021-07-07
Monitor Bracket Assembly Wear May Cause Fall Hazard for Medical Imaging Equipment
Philips medical imaging equipment monitor bracket assemblies may detach due to unrecognized shaft wear, risking the monitor falling and causing serious injury to patients, operators, or bystanders.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
Category
Distribution
10 states
HighFDA (Devices)··2021-07-07
Philips Monitor Bracket Assembly falls due to shaft wear in medical imaging systems
Philips monitor bracket assemblies for CT/PET imaging systems may detach due to shaft wear, posing a risk of the monitor falling and causing serious injury to patients, operators, or bystanders.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
Category
Distribution
10 states
HighFDA (Devices)··2021-07-07
Monitor bracket assembly recalled for detachment hazard on CT imaging systems
Philips is recalling 1,301 monitor bracket assemblies for CT/PET-CT imaging systems due to shaft wear that could cause detachment from the suspension arm, potentially resulting in the monitor falling and serious injury.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251 - Brillia
Category
Distribution
10 states
HighFDA (Devices)··2021-07-07
Philips CT Monitor Bracket May Detach Due to Shaft Wear
Philips CT fluoroscopy monitors may develop bracket shaft wear that could lead to the monitor detaching and falling while attached to cables.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
Category
Distribution
10 states
HighFDA (Devices)··2021-07-07
Philips Medical Monitor Bracket May Detach from Ceiling Mount
Philips medical imaging monitors with worn bracket assembly shafts may detach from ceiling suspensions and fall on patients, operators, or staff. No injuries have been reported.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT
Category
Distribution
10 states