Class 2 Device Recall Philips Healthcare Brilliance 64

• Date Initiated by Firm: October 18, 2018
• Create Date: November 30, 2018
• Recall Status: Terminated on August 03, 2021
• Recall Number: Z-0543-2019
• Recall Event ID: 81569
• 510(K)Number: K033326
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Brilliance 64, Model 728231 ; ; Product Usage:; Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
• Code Information: System Serial Number: 335 1489 1897 3491 4001 4003 4016 4021 9009 9029 9030 9033 9035 9037 9038 9040 9041 9043 9044 9045 9047 9048 9051 9052 9054 9056 9058 9059 9062 9064 9065 9066 9067 9068 9069 9070 9071 9072 9073 9074 9075 9077 9080 9081 9086 9087 9089 9092 9093 9096 9098 9099 9104 9105 9106 9107 9108 9112 9117 9118 9120 9121 9122 9134 9135 9137 9138 9139 9140 9142 9143 9148 9151 9152 9156 9159 9160 9162 9163 9166 9168 9171 9172 9173 9177 9187 9190 9194 9195 9196 9197 9201 9202 9205 9206 9208 9213 9214 9215 9216 9217 9218 9234 9235 9236 9243 9250 9251 9255 9259 9263 9268 9269 9272 9280 9286 9367 9501 9502 9503 9504 9505 9506 9507 9508 9509 9510 9511 9512 9513 9514 9515 9516 9517 9518 9519 9520 9521 9522 9523 9524 9525 9526 9527 9528 9529 9530 9531 9532 9533 9534 9535 9536 9537 9538 9539 9540 9541 9542 9543 9544 9545 9546 9547 9548 9549 9550 9551 9552 9553 9554 9555 9556 9557 9558 9559 9560 9561 9562 9563 9564 9565 9566 9567 9568 9569 9570 9571 9572 9573 9574 9575 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95424-OLD 95459_ 95517_ 95567_ 95585/11737/80302 95631-OLD 9701_DUMMY 9801A 9851T 9944_ D10156 DUMMY GYULA02 PROJ5041009 S/N95611 SN90137 SN95514 SN95517 SN95726
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Holly Wright Lee; 440-483-2015
• Manufacturer Reason for Recall: There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
• FDA Determined Cause: Process control
• Action: On October 18, 2018, Philips notices to their customers via courier service. Customers were advised to take the following actions: If any unusual noise is heard, discontinue use of the system immediately and contact your Philips representative for support. Field Order Change (FCO) 72800703 will be deployed to initiate an inspection of the front gantry cover. If the inspection finds evidence of weakening at this connection point, a temporary repair solution will be put in place to secure the cover for continued system use. FCO 72800704 will then be deployed to replace the affected front cover. A Philips Field Service Engineer will contact you to schedule the inspection of your system. Customers in need of further information or support concerning this issue, please contact your local Philips representative (North America & Canada) 1-800-722-9377.
• Quantity in Commerce: 6,343 units in total
• Distribution: US Nationwide Distribution
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.