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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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  Class 2 Device Recall Philips see related information
Date Initiated by Firm May 01, 2021
Create Date June 30, 2021
Recall Status1 Open3, Classified
Recall Number Z-1982-2021
Recall Event ID 87974
510(K)Number K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
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
Code Information 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    
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action Philips issued URGENT- Field Safety Notice Medical Device Correction letter on 5/1/21 FSN 72800751 and FSN 88200530 . Letter states reason for recall, health risk and action to take: " Be aware of this hazard when the safety clip is missing from the joint assembly between the Monitor Bracket Assembly and the Ceiling Suspension Arm. " Inspect the joint area of their CCT DVI Ceiling Mount Arm (the circled area in picture at theright) and observe that the safety clip is installed (as depicted in pictures below). " When this hazard occurs, the monitor may become difficult to rotate relative to the Suspension Arm. When these symptoms are recognized, in order to avoid the occurrence of a hazardous situation, take the following actions: stop using the suspension monitor clinically move the monitor arm away from any person call Philips Service for repairs. Please acknowledge the receipt of this notice by completing, signing, and returning the form attached at the end of this communication to the indicated email address. Philips will inspect systems via Field Change Order FCO 88200530. Systems failing the inspection will be corrected via Field Change Order FCO 882531 For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
Quantity in Commerce 1,301 Monitor Bracket Assemblies total
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, ZW.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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