BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras des...
FDA Device Recall #Z-0510-2018 — Class II — December 15, 2017
Recall Summary
| Recall Number | Z-0510-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 15, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems (Cleveland) Inc |
| Location | Cleveland, OH |
| Product Type | Devices |
| Quantity | 1387 in total |
Product Description
BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
Reason for Recall
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
Distribution Pattern
Worldwide Distribution - US Nationwide
Lot / Code Information
BrightView X, Model # 882478 Serial Numbers: 11000044 11000006 11000033 11000025 11000105 11000016 11000072 11000116 11000003 11000018 11000066 11000047 11000101 11000065 11000114 11000078 11000051 11000046 11000026 11000007 11000010 11000027 11000032 11340001 11000055 11000070 11000084 11000088 11000068 11000052 11000057 11000050 11000067 11000102 11000061 11000095 11000023 11000094 11000060 11000054 11340004 11000083 11000091 11000098 4000570 11000063 11000062 11000013 11000015 11000035 11000081 11000009 11000017 11000110 11000090 11000107 11340003 11000056 11000029 11000100 11000019 11000034 11000020 11000112 11000086 11000045 11000092 11000037 11000106 11000038 11000059 11000064 11000039 11000087 11000004 11000058 11000030 11340005 11000113 11000117 11000011 11000118 11000074 11000075 11000036 11000104 11000103 11000071 11340002 11000089 11000012 11000041 11000042 11000043 11000049 11000014 11000099 11000022 11000031 11000005 11000028 11000073 11000040 11000077 11000008 11000048 11000093 11000096 11000097 11000069 11000079 11000080 11000024 11000076 11000085 11000108 11000109 11000115
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.