Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sect...
FDA Device Recall #Z-1872-2016 — Class II — April 8, 2016
Recall Summary
| Recall Number | Z-1872-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 8, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems (Cleveland) Inc |
| Location | Cleveland, OH |
| Product Type | Devices |
| Quantity | 158 units |
Product Description
Brilliance 64 Computed Tomography X-ray Systems Product Usage: 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
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
Lot / Code Information
Model No. 728231; S/N: 4001 5169 9056 9074 9099 9134 9251 9515 9529 9538 9541 9548 9549 9554 9559 9561 9573 9574 9600 9618 9625 9631 9638 9646 9653 9656 9659 9667 9670 9678 9686 9689 9703 9711 9738 9740 9755 9763 9782 9805 9811 9822 9833 9837 9838 9859 9862 9890 9898 9901 9909 9910 9917 9920 9922 9923 9927 9930 9933 9983 9989 9993 10012 10014 10021 10024 10042 10047 10050 10051 10077 10092 10099 10106 10150 10179 10180 10193 10206 10208 10213 10216 10250 10299 10302 10379 10394 10422 10446 10470 10514 10610 10671 10698 10743 29002 29014 29015 29056 29107 29115 90124 90154 91003 95022 95024 95130 95157 95191 95197 95213 95222 95236 95239 95244 95258 95261 95343 95349 95351 95364 95374 95387 95399 95409 95410 95439 95475 95496 95504 95507 95512 95524 95538 95551 95563 95614 95616 95668 95688 95691 95707 95811 122856 122863 122866 122877 122902 122921 122922 122953 123070 123092 123096 123116 123117 300062 95341A
Other Recalls from Philips Medical Systems (Cleveland) Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2570-2025 | Class II | Pinnacle Radiation Therapy Planning System: ... | Aug 5, 2025 |
| Z-2239-2025 | Class II | Pinnacle 3 with TumorLOC, (870258) Radiation Th... | Jul 17, 2025 |
| Z-1744-2022 | Class II | Pinnacle3 Radiation Therapy Planning System, Mo... | Aug 30, 2022 |
| Z-0213-2020 | Class I | Forte Gamma Camera System is intended to produc... | Sep 19, 2019 |
| Z-0217-2020 | Class I | Forte Gamma Camera System is intended to produc... | Sep 19, 2019 |
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.