The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These de...
FDA Device Recall #Z-2245-2012 — Class II — August 3, 2012
Recall Summary
| Recall Number | Z-2245-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 3, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems (Cleveland) Inc |
| Location | Cleveland, OH |
| Product Type | Devices |
| Quantity | 126 units |
Product Description
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems that are 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 analysis and display equipment, patient, and equipment supports, components and accessories
Reason for Recall
The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.
Distribution Pattern
Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, DC, FL, GA, KY, MD, MI, MN, MS, ND, NM, NY, OH, OK, SC, TN, TX, VT, WA, and WI and the countries of: Austria, China, Denmark, France, Germany, Iceland, Japan, Netherlands, South Africa, Sweden, Switzerland, United Kingdom. There were two government consignees. There were no Canadian consignees.
Lot / Code Information
System Code # 728243, Serial #s: 7392, 7394, 7399, 7405, 7406, 7429, 7433, 7440, 7457, 7465, 7469, 7479, 7481, 7487, 7488, 7491, 7502, 7506, 7507, 7517, 7518, 7520, 7521, 7532, 7539, 7545, 7547, and 7556. System Code # 728244, Serial #s: 7190, 7195, 7318, 7383, 7427, 7430, 7510, and 7533. System Code #728256, Serial #s: 3163, 3500, 3500, 5623, 5655, 5655, 5666, 5670, 5715, 5724, 5747, 5773, 5776, 5813, 5836, 5855, 5862, 5868, 5877, 5897, 5911, 5911, 5916, 5935, 5969, and 5997. System Code #728251, Serial #: 4051. System Code # 728246, Serial #s: 5547, 5585, 5791, 5803, 5876, 5974. System Code # 728235, Serial #s: 9233, 9234, 9261, 95022. System Code # 728231, Serial #s: 9867, 9925, 9931, 9980, 9996, 10009, 10011, 10015, 10028, 10036, 10042, 10045, 10050, 10052, 10062, 10063, 10064, 10077, 10079, 10081, 10096, 10099, 10102, 10111, 10114, 10120, 10122, 10133, 10135, 10136, 10137, 10139, 10145, 10148, 10149, 10151, 10153, 10166, 10170, 10172, 10198, 10203, 95109, 95348, 95563.
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.