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Brilliance 16, Model number 728246 Product Usage: Computed Tomography X-ray systems intended ...

FDA Device Recall #Z-2655-2016 — Class II — July 20, 2016

Recall Summary

Recall Number Z-2655-2016
Classification Class II — Moderate risk
Date Initiated July 20, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Medical Systems (Cleveland) Inc
Location Cleveland, OH
Product Type Devices
Quantity 192

Product Description

Brilliance 16, Model number 728246 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.

Reason for Recall

After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.

Distribution Pattern

US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA, MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM, NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY

Lot / Code Information

728246 -- Brilliance 16 3010 3017 3031 3040 3043 3070 3072 3085 3090 3117 3149 3216 3247 3293 3314 5006 5012 5018 5020 5024 5026 5028 5030 5031 5035 5044 5045 5052 5053 5054 5055 5058 5059 5060 5064 5069 5070 5081 5086 5088 5091 5093 5097 5099 5103 5107 5108 5110 5111 5115 5116 5118 5120 5123 5126 5127 5128 5131 5138 5140 5155 5160 5161 5163 5166 5184 5186 5188 5190 5191 5192 5193 5195 5197 5208 5209 5216 5219 5235 5236 5238A 5270 5272 5279 5282 5285 5287 5294 5295 5315 5316 5350 5354 5357 5360 5368 5394 5433 5434 5443 5453 5457 5480 5487 5501 5502 5505 5519 5523 5526 5554 5572 5573 5576 5609 5615 5633 5647 5653 5683 5723 5758 5762 5764 5771 5811 5897 5929 5937 5956 5974 5995 6021 6022 6031 6033 6048 6053 6072 6220 6229 6243 6280 6283 6298 6309 6321 6360 6375 6405 6426 6441 6465 6474 6484 6503 6511 6517 6519 6523 6549 6559 30049 32287 50011 50053 50087 50180 3123 5674 6555 32366 3465 50181 5135 5237 3179 3411 5009 5048 5077 5412 6154 30011 30110 5101 5181 3324 5405 3050 3441 6387

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Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

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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