Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP

Class I - Dangerous

🏥 Medical Devices Recalled: May 1, 2021 Philips North America Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
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/A 728306 85101 (01)00884838059474(21)85101 728306 100632 N/A 728306 100062 N/A 728306 100288 N/A 728306 100365 N/A 728306 100169 N/A 728306 100858 (01)00884838059474(21)100858 728306 100446 N/A 728306 100813 (01)00884838059474(21)100813 728306 100729 N/A 728306 100601 N/A 728306 100205 N/A 728306 100038 N/A 728306 100302 N/A 728306 100723 N/A 728306 N/A 728306 100086 (01)00884838059474(21)100086 728306 100791 (01)00884838059474(21)100791 728306 100193 N/A 728306 85218 (01)00884838059474(21)85218 728306 100638 N/A 728306 100440 N/A 728306 100223 N/A 728306 100645 N/A 728306 100414 N/A 728306 100260 N/A 728306 100314 N/A 728306 100339 N/A 728306 85012 N/A 728306 100299 N/A 728306 100115 N/A 728306 100278 N/A 728306 85097 (01)00884838059474(21)85097 728306 100357 N/A 728306 100412 N/A 728306 100409 N/A 728306 100794 (01)00884838059474(21)100794 728306 100123 N/A 728306 100622 N/A 728306 100631 N/A 728306 100349 N/A 728306 100147 N/A 728306 85029 N/A 728306 100681 N/A 728306 87008 (01)00884838059474(21)87008 728306 85221 (01)00884838059474(21)85221 728306 100144 N/A 728306 85038 N/A 728306 100372 N/A 728306 100044 N/A 728306 100623 N/A 728306 85078 N/A 728306 85202 (01)00884838059474(21)85202 728306 85205 (01)00884838059474(21)85205 728306 100341 N/A 728306 100503 N/A 728306 100325 N/A 728306 100290 N/A 728306 100406 N/A 728306 85127 (01)00884838059474(21)85127 728306 100634 N/A 728306 100064 N/A 728306 100759 (01)00884838059474(21)100759 728306 100040 N/A 728306 100679 N/A 728306 100654 N/A 728306 100416 N/A 728306 100396 N/A 728306 85276 (01)00884838059474(21)85276 728306 100257 N/A 728306 100466 N/A 728306 100453 N/A 728306 100452 N/A 728306 85230 N/A 728306 100351 N/A 728306 85138 (01)00884838059474(21)85138 728306 85285 (01)00884838059474(21)85285 728306 100689 N/A 728306 100626 N/A 728306 100454 N/A 728306 100486 N/A 728306 100633 N/A 728306 87047 (01)00884838059474(21)87047 728306 85283 (01)00884838059474(21)85283 728306 N/A N/A 728306 85145 (01)00884838059474(21)85145 728306 100821 (01)00884838059474(21)100821 728306 100368 N/A 728306 85080 (01)00884838059474(21)85080 728306 100804 (01)00884838059474(21)100804 728306 100802 (01)00884838059474(21)100802 728306 87036 (01)00884838059474(21)87036 728306 100806 (01)00884838059474(21)100806 728306 100501 N/A 728306 100373 N/A 728306 100853 (01)00884838059474(21)100853 728306 100661 N/A 728306 100381 N/A 728306 100852 (01)00884838059474(21)100852 728306 100287 N/A 728306 100045 N/A 728306 85099 (01)00884838059474(21)85099 728306 100462 N/A 728306 85286 (01)00884838059474(21)85286 728311 200119 N/A 728311 83006 (01)00884838059481(21)83006 728311 83009 N/A 728311 200090 N/A 728311 200039 N/A 728311 200137 N/A 728311 200052 N/A 728311 200058 N/A 728311 200078 N/A 728311 83005 (01)00884838059481(21)83005 728311 200011 N/A 728311 200006 N/A 728311 200022 N/A 728311 200018 N/A 728311 200214 N/A 728311 200093 N/A 728311 200101 N/A 728311 200107 N/A 728311 200138 N/A 728311 200121 N/A 728311 200021 (01)00884838059474(21)200021 728311 200213 N/A 728311 200068 N/A 728311 200127 N/A 728311 83002 (01)00884838059481(21)83002 728311 200047 N/A 728311 644 N/A 728311 200089 N/A 728311 200082 N/A 728311 200112 N/A 728311 200217 (01)00884838059481(21)200217 728311 200205 N/A 728311 200203 N/A
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Philips North America Llc
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP

Product Codes/Lot Numbers:

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/A 728306 85101 (01)00884838059474(21)85101 728306 100632 N/A 728306 100062 N/A 728306 100288 N/A 728306 100365 N/A 728306 100169 N/A 728306 100858 (01)00884838059474(21)100858 728306 100446 N/A 728306 100813 (01)00884838059474(21)100813 728306 100729 N/A 728306 100601 N/A 728306 100205 N/A 728306 100038 N/A 728306 100302 N/A 728306 100723 N/A 728306 N/A 728306 100086 (01)00884838059474(21)100086 728306 100791 (01)00884838059474(21)100791 728306 100193 N/A 728306 85218 (01)00884838059474(21)85218 728306 100638 N/A 728306 100440 N/A 728306 100223 N/A 728306 100645 N/A 728306 100414 N/A 728306 100260 N/A 728306 100314 N/A 728306 100339 N/A 728306 85012 N/A 728306 100299 N/A 728306 100115 N/A 728306 100278 N/A 728306 85097 (01)00884838059474(21)85097 728306 100357 N/A 728306 100412 N/A 728306 100409 N/A 728306 100794 (01)00884838059474(21)100794 728306 100123 N/A 728306 100622 N/A 728306 100631 N/A 728306 100349 N/A 728306 100147 N/A 728306 85029 N/A 728306 100681 N/A 728306 87008 (01)00884838059474(21)87008 728306 85221 (01)00884838059474(21)85221 728306 100144 N/A 728306 85038 N/A 728306 100372 N/A 728306 100044 N/A 728306 100623 N/A 728306 85078 N/A 728306 85202 (01)00884838059474(21)85202 728306 85205 (01)00884838059474(21)85205 728306 100341 N/A 728306 100503 N/A 728306 100325 N/A 728306 100290 N/A 728306 100406 N/A 728306 85127 (01)00884838059474(21)85127 728306 100634 N/A 728306 100064 N/A 728306 100759 (01)00884838059474(21)100759 728306 100040 N/A 728306 100679 N/A 728306 100654 N/A 728306 100416 N/A 728306 100396 N/A 728306 85276 (01)00884838059474(21)85276 728306 100257 N/A 728306 100466 N/A 728306 100453 N/A 728306 100452 N/A 728306 85230 N/A 728306 100351 N/A 728306 85138 (01)00884838059474(21)85138 728306 85285 (01)00884838059474(21)85285 728306 100689 N/A 728306 100626 N/A 728306 100454 N/A 728306 100486 N/A 728306 100633 N/A 728306 87047 (01)00884838059474(21)87047 728306 85283 (01)00884838059474(21)85283 728306 N/A N/A 728306 85145 (01)00884838059474(21)85145 728306 100821 (01)00884838059474(21)100821 728306 100368 N/A 728306 85080 (01)00884838059474(21)85080 728306 100804 (01)00884838059474(21)100804 728306 100802 (01)00884838059474(21)100802 728306 87036 (01)00884838059474(21)87036 728306 100806 (01)00884838059474(21)100806 728306 100501 N/A 728306 100373 N/A 728306 100853 (01)00884838059474(21)100853 728306 100661 N/A 728306 100381 N/A 728306 100852 (01)00884838059474(21)100852 728306 100287 N/A 728306 100045 N/A 728306 85099 (01)00884838059474(21)85099 728306 100462 N/A 728306 85286 (01)00884838059474(21)85286 728311 200119 N/A 728311 83006 (01)00884838059481(21)83006 728311 83009 N/A 728311 200090 N/A 728311 200039 N/A 728311 200137 N/A 728311 200052 N/A 728311 200058 N/A 728311 200078 N/A 728311 83005 (01)00884838059481(21)83005 728311 200011 N/A 728311 200006 N/A 728311 200022 N/A 728311 200018 N/A 728311 200214 N/A 728311 200093 N/A 728311 200101 N/A 728311 200107 N/A 728311 200138 N/A 728311 200121 N/A 728311 200021 (01)00884838059474(21)200021 728311 200213 N/A 728311 200068 N/A 728311 200127 N/A 728311 83002 (01)00884838059481(21)83002 728311 200047 N/A 728311 644 N/A 728311 200089 N/A 728311 200082 N/A 728311 200112 N/A 728311 200217 (01)00884838059481(21)200217 728311 200205 N/A 728311 200203 N/A

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1990-2021

Related Recalls

Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

Philips North America

Class I - Dangerous

Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.

Oct 27, 2025 Other Medical Devices View Details →

IntelliVue MP90. Product Number: M8010A.

Philips North America

Class I - Dangerous

Potential issue where the IntelliVue monitors did not alarm.

Oct 31, 2025 Infusion Pumps Nationwide View Details →

IntelliVue MP30. Product Number: M8002A.

Philips North America

Class I - Dangerous

Potential issue where the IntelliVue monitors did not alarm.

Oct 31, 2025 Infusion Pumps Nationwide View Details →