🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: May 1, 2021 Philips North America Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Model/ Serial Number/UDI: N/A 728235 90040 728235 90191 728235 90192 728235 90061 728235 29090 728235 90111 728235 29042 728235 90165 728235 29082 728235 29152 728235 90054 728235 90087 728235 90122 728235 90142 728235 90104 728235 90075 728235 9237 728235 90110 728235 90084 728235 90208 728235 9047 728235 90125 728235 90171 728235 90212 728235 90056 728235 90227 728235 90164 728235 90051 728235 90035 728231 9367 728231 95709 728231 10625 728231 10379 728231 9900 728231 10630 728231 10755 728231 10758 728231 90094.. 728231 9524 728231 95443 728231 95463 728231 90046 728231 95706 728231 95305 728231 10139 728231 29086 728231 10273 728231 95046 728231 95044 728231 95324 728231 90180 728231 95062 728231 95155 728231 95206 728231 95122 728231 95159 728231 90199 728231 95434 728231 95717 728231 95328 728231 95401 728231 10393 728231 90154 728231 95365 728231 95457 728231 95054 728231 95267 728231 95156 728231 95515 728231 10659 728231 10635 728231 29056 728231 95601 728231 95712 728231 95404 728231 90141 728231 90153 728231 95087 728231 95029 728231 90045 728231 95038 728231 90100 728231 95023 728231 95089 728231 90152 728231 90151 728231 64081 728231 10060 728231 90042 728231 90077 728231 95345 728231 9755 728231 90098 728231 9898 728231 9621 728231 9859 728231 90106 728231 10067 728231 9670 728231 9937 728231 9066 728231 10733 728231 90128 728231 9703 728231 9716 728231 9151 728231 9655 728231 10698 728231 9805 728231 10111 728231 9862 728231 9045 728231 10221 728231 10773 728231 9584 728231 9948 728231 95036 728231 9960 728231 90158 728231 9074 728231 95160 728231 95695 728231 10470 728231 29049 728231 9166 728231 90033 728231 95721 728231 10628 728231 29135 728231 95480 728231 9793 728231 29044 728231 9168 728231 95633 728231 9554 728231 9882 728231 9875 728231 10381 728231 10000 728231 9215 728231 95315 728231 95204 728231 10203 728231 10742 728231 10596 728231 90221 728231 95238 728231 90186 728231 10651 728231 10503 728231 10407 728231 10409 728231 90058 728231 10686 728231 10580 728231 95374 728231 90139 728231 64051 728231 95020 728231 95058 728231 95096 728231 10136 728231 9761 728231 9757 728231 90081 728231 10316 728231 9802 728231 N/A 728231 90056 728231 95035 728231 95143 728231 3491 728231 10446 728231 90227 728231 95271 728231 10551 728231 90176 728231 9969 728231 9656 728231 90099 728231 95720 728231 95719 728231 95168 728231 95669 728231 10506 728231 10065 728231 9579 728231 95704 728231 10600 728231 9950 728231 95330 728231 10066 728231 90057 728232 122850 728317 345281 (01)00884838059528(21)345281 728317 345321 (01)00884838059528(21)345321 728317 345217 N/A 728317 345306 (01)00884838059528(21)345306 728317 345300 (01)00884838059528(21)345300 728317 345003 N/A 728317 345213 N/A 728317 345307 (01)00884838059528(21)345307 728317 345287 (01)00884838059528(21)345287 728317 345293 (01)00884838059528(21)345293 728317 345021 N/A 728317 345201 N/A 728317 345252 N/A 728232 122850 N/A 728317 N/A 728317 340003 N/A 728317 260003 N/A 728317 345210 N/A 728317 345291 (01)00884838059528(21)345291 728317 345311 (01)00884838059528(21)345311 728317 345277 (01)00884838059528(21)345277 728317 345165 (01)00884838059528(21)345165 728317 345317 (01)00884838059528(21)345317 728317 345024 N/A 728317 345002 N/A 728317 345318 (01)00884838059528(21)345318 728317 345279 (01)00884838059528(21)345279 728317 345205 N/A 728317 N/A N/A 728317 345206 N/A 728317 345023 N/A 728317 345253 N/A 728317 345220 N/A 728317 345275 (01)00884838059528(21)345275 728317 345257 N/A 728317 345005 N/A 728317 345260 N/A 728317 345269 N/A 728317 345212 N/A 728317 345241 N/A 728317 345231 N/A 728317 345288 (01)00884838059528(21)345288
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 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

Product Codes/Lot Numbers:

Model/ Serial Number/UDI: N/A 728235 90040 728235 90191 728235 90192 728235 90061 728235 29090 728235 90111 728235 29042 728235 90165 728235 29082 728235 29152 728235 90054 728235 90087 728235 90122 728235 90142 728235 90104 728235 90075 728235 9237 728235 90110 728235 90084 728235 90208 728235 9047 728235 90125 728235 90171 728235 90212 728235 90056 728235 90227 728235 90164 728235 90051 728235 90035 728231 9367 728231 95709 728231 10625 728231 10379 728231 9900 728231 10630 728231 10755 728231 10758 728231 90094.. 728231 9524 728231 95443 728231 95463 728231 90046 728231 95706 728231 95305 728231 10139 728231 29086 728231 10273 728231 95046 728231 95044 728231 95324 728231 90180 728231 95062 728231 95155 728231 95206 728231 95122 728231 95159 728231 90199 728231 95434 728231 95717 728231 95328 728231 95401 728231 10393 728231 90154 728231 95365 728231 95457 728231 95054 728231 95267 728231 95156 728231 95515 728231 10659 728231 10635 728231 29056 728231 95601 728231 95712 728231 95404 728231 90141 728231 90153 728231 95087 728231 95029 728231 90045 728231 95038 728231 90100 728231 95023 728231 95089 728231 90152 728231 90151 728231 64081 728231 10060 728231 90042 728231 90077 728231 95345 728231 9755 728231 90098 728231 9898 728231 9621 728231 9859 728231 90106 728231 10067 728231 9670 728231 9937 728231 9066 728231 10733 728231 90128 728231 9703 728231 9716 728231 9151 728231 9655 728231 10698 728231 9805 728231 10111 728231 9862 728231 9045 728231 10221 728231 10773 728231 9584 728231 9948 728231 95036 728231 9960 728231 90158 728231 9074 728231 95160 728231 95695 728231 10470 728231 29049 728231 9166 728231 90033 728231 95721 728231 10628 728231 29135 728231 95480 728231 9793 728231 29044 728231 9168 728231 95633 728231 9554 728231 9882 728231 9875 728231 10381 728231 10000 728231 9215 728231 95315 728231 95204 728231 10203 728231 10742 728231 10596 728231 90221 728231 95238 728231 90186 728231 10651 728231 10503 728231 10407 728231 10409 728231 90058 728231 10686 728231 10580 728231 95374 728231 90139 728231 64051 728231 95020 728231 95058 728231 95096 728231 10136 728231 9761 728231 9757 728231 90081 728231 10316 728231 9802 728231 N/A 728231 90056 728231 95035 728231 95143 728231 3491 728231 10446 728231 90227 728231 95271 728231 10551 728231 90176 728231 9969 728231 9656 728231 90099 728231 95720 728231 95719 728231 95168 728231 95669 728231 10506 728231 10065 728231 9579 728231 95704 728231 10600 728231 9950 728231 95330 728231 10066 728231 90057 728232 122850 728317 345281 (01)00884838059528(21)345281 728317 345321 (01)00884838059528(21)345321 728317 345217 N/A 728317 345306 (01)00884838059528(21)345306 728317 345300 (01)00884838059528(21)345300 728317 345003 N/A 728317 345213 N/A 728317 345307 (01)00884838059528(21)345307 728317 345287 (01)00884838059528(21)345287 728317 345293 (01)00884838059528(21)345293 728317 345021 N/A 728317 345201 N/A 728317 345252 N/A 728232 122850 N/A 728317 N/A 728317 340003 N/A 728317 260003 N/A 728317 345210 N/A 728317 345291 (01)00884838059528(21)345291 728317 345311 (01)00884838059528(21)345311 728317 345277 (01)00884838059528(21)345277 728317 345165 (01)00884838059528(21)345165 728317 345317 (01)00884838059528(21)345317 728317 345024 N/A 728317 345002 N/A 728317 345318 (01)00884838059528(21)345318 728317 345279 (01)00884838059528(21)345279 728317 345205 N/A 728317 N/A N/A 728317 345206 N/A 728317 345023 N/A 728317 345253 N/A 728317 345220 N/A 728317 345275 (01)00884838059528(21)345275 728317 345257 N/A 728317 345005 N/A 728317 345260 N/A 728317 345269 N/A 728317 345212 N/A 728317 345241 N/A 728317 345231 N/A 728317 345288 (01)00884838059528(21)345288

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1982-2021

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