Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce c...
FDA Device Recall #Z-1493-2017 — Class II — February 23, 2017
Recall Summary
| Recall Number | Z-1493-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 23, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems (Cleveland) Inc |
| Location | Cleveland, OH |
| Product Type | Devices |
| Quantity | 67 |
Product Description
Brilliance BigBore Radiology CT - 728244 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. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
Reason for Recall
Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
Distribution Pattern
Worldwide Distribution - US to AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, TX & WI; Internationally to the following countries: Australia, Austria, Canada, China, Czech Republic, Germany, India, Israel, Jordan, Korea, Mexico, New Cldonia, Romania, Russian Federation, Turkey, & United Kingdom.
Lot / Code Information
System Serial Number - 76001, 76005, 76007, 76009, 76013, 76014, 76017, 76018, 76019, System Serial Number - Unique Device Identifier 76058 (01)00884838059450(21)76058 76033 (01)00884838059450(21)76033 76048 (01)00884838059450(21)76048 76059 (01)00884838059450(21)76059 76015 (01)00884838059450(21)76015 76063 (01)00884838059450(21)76063 76066 (01)00884838059450(21)76066 76049 (01)00884838059450(21)76049 76040 (01)00884838059450(21)76040 76032 (01)00884838059450(21)76032 76061 (01)00884838059450(21)76061 76031 (01)00884838059450(21)76031 76006 (01)00884838059450(21)76006 76041 (01)00884838059450(21)76041 76035 (01)00884838059450(21)76035 76038 (01)00884838059450(21)76038 76065 (01)00884838059450(21)76065 76064 (01)00884838059450(21)76064 76053 (01)00884838059450(21)76053 76050 (01)00884838059450(21)76050 76060 (01)00884838059450(21)76060 76036 (01)00884838059450(21)76036 76056 (01)00884838059450(21)76056 76055 (01)00884838059450(21)76055 76037 (01)00884838059450(21)76037 76051 (01)00884838059450(21)76051 76044 (01)00884838059450(21)76044 76039 (01)00884838059450(21)76039 76012 (01)00884838059450(21)76012 76026 (01)00884838059450(21)76026 760016 (01)00884838059450(21)760016 760001 (01)00884838059450(21)760001 760005 (01)00884838059450(21)760005 760004 (01)00884838059450(21)760004 760003 (01)00884838059450(21)760003 760007 (01)00884838059450(21)760007 76072 (01)00884838059450(21)76072 76062 (01)00884838059450(21)76062 76043 (01)00884838059450(21)76043 760013 (01)00884838059450(21)760013 760014 (01)00884838059450(21)760014 76029 (01)00884838059450(21)76029 760010 (01)00884838059450(21)760010 76027 (01)00884838059450(21)76027 760011 (01)00884838059450(21)760011 760009 (01)00884838059450(21)760009 760006 (01)00884838059450(21)760006 76045 (01)00884838059450(21)76045 76054 (01)00884838059450(21)76054 76069 (01)00884838059450(21)76069 76034 (01)00884838059450(21)76034 76030 (01)00884838059450(21)76030 76047 (01)00884838059450(21)76047 76057 (01)00884838059450(21)76057 76028 (01)00884838059450(21)76028 76068 (01)00884838059450(21)76068 760012 (01)00884838059450(21)760012 760002 (01)00884838059450(21)760002
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
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.