Class 2 Device Recall Philips

• Date Initiated by Firm: May 01, 2021
• Create Date: June 30, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1981-2021
• Recall Event ID: 87974
• 510(K)Number: K012009
• 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 16 Power, Brilliance 16/10/6 Water/Air; 728240/728245/728246 - Brilliance 16; 728255/728256/728266 - Brilliance 6; 728250/728251 - Brilliance 10; 728260 - Extended Brilliance Workspace
• Code Information: Model/ Serial Number/UDI: N/A 728240 60005 728240 60003 728240 6017 728240 60012 728240 60007 728240 6105 728240 6136 728240 60016 728240 60014 728240 60006 728240 6156 728240 5080 728240 60011 728240 6109 728240 5413 728245 3371 728245 3394 728245 3484_ 728245 3500 728245 3377 728245 . 728245 3448 728245 3483 728245 3443 728245 3360 728245 9732 728245 3426 728245 3429 728245 6109 728245 3408 728245 3473 728245 3419 728246 260032 728246 6444 728246 6265 728246 5452 728246 40018 728246 6618 728246 50081 728246 50014 728246 50026 728246 6556 728246 5449 728246 50029 728246 5485 728246 5942 728246 50046 728246 30019 728246 5313 728246 5013 728246 50096 728246 5207 728246 5916 728246 50094 728246 30033 728246 50032 728246 5174 728246 6503 728246 6519 728246 6511 728246 5773 728246 5816 728246 260015 728246 6491 728246 5296 728246 50188 728246 30103 728246 5041 728246 4017 728246 5632 728246 50010 728246 5658 728246 3382 728246 30063 728246 5515 728246 5343 728246 50053 728246 5621 728246 6141 728246 50209 728246 5431 728246 9374 728246 50005 728246 6632 728246 50025 728246 30109 728246 5754 728246 50211 728246 5078 728246 3170 728246 6255 728246 3014 728246 5097 728246 6612 728246 5812 728246 60013 728246 6533 728246 50134 728255 9802 728255 9728 728255 9795 728256 3382 728256 30103 728256 30100 728256 3014 728256 3296 728256 3463 728256 3344 728256 30029 728256 3113 728256 3063 728256 30110 728256 30063 728266 3635 728250 2579 728251 40008 728251 40004 728251 40006 728251 4005 728251 3008 728251 40021 728251 40019 728260 7330 N/A 728260 12323 N/A
• 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: 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 = MARCONI MEDICAL SYSTEMS, INC.