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Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems in...

FDA Device Recall #Z-0545-2019 — Class II — October 18, 2018

Recall Summary

Recall Number Z-0545-2019
Classification Class II — Moderate risk
Date Initiated October 18, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Medical Systems (Cleveland) Inc
Location Cleveland, OH
Product Type Devices
Quantity 6,343 units in total

Product Description

Brilliance 16 Slice (Power), Model 728240 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

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

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

System Serial Number: 3004 3046 3100 3236 3406 3723 5003 5039 5043 5047 5071 5080 5157 5251 5280 5284 5345 5356 5374 5390 5395 5413 5430 5455 5467 5495 5499 5500 5512 5527 5638 5822 6006 6009 6010 6011 6013 6016 6017 6020 6021 6022 6023 6024 6026 6027 6028 6029 6030 6031 6032 6033 6034 6035 6036 6037 6038 6039 6041 6042 6043 6045 6046 6047 6048 6049 6051 6052 6053 6054 6055 6056 6057 6058 6059 6060 6062 6063 6064 6065 6066 6067 6068 6069 6070 6071 6072 6073 6074 6075 6077 6078 6079 6080 6081 6082 6083 6084 6085 6086 6087 6088 6089 6090 6093 6095 6096 6097 6099 6100 6101 6102 6103 6104 6105 6106 6107 6108 6109 6110 6111 6112 6113 6114 6115 6116 6117 6118 6119 6121 6122 6123 6124 6125 6126 6128 6129 6130 6131 6132 6133 6134 6135 6136 6137 6138 6139 6140 6141 6142 6143 6144 6145 6146 6147 6148 6149 6150 6151 6152 6153 6154 6155 6156 6157 6159 6160 6161 6162 6163 60001 60002 60003 60004 60005 60006 60007 60008 60009 60010 60011 60012 60013 60014 60016 60017 60018 60019 60020 60021 60022 60023 60024 60025 60027 60028 60029 554198 557626 18795777 62986074 1326-01 60021/7262 6111-OLD 6127/7446 6152/8484 NLCCT

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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