BrightView X, Gamma Camera, Product Code 882478
FDA Device Recall #Z-0678-2024 — Class II — November 30, 2023
Recall Summary
| Recall Number | Z-0678-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 30, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America |
| Location | Cambridge, MA |
| Product Type | Devices |
| Quantity | 59 US; 59 OUS |
Product Description
BrightView X, Gamma Camera, Product Code 882478
Reason for Recall
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution worldwide.
Lot / Code Information
No UDI Serial numbers 11000072 11000116 11000007 11000010 11340001 11000027 11000032 4000570 11000041 11000092 11000113 11340003 11000044 11000006 11000033 11000025 11000105 11000016 11000003 11000018 11000065 11000047 11000066 11000101 11000107 11000090 11000029 11000056 11000026 11000046 11000051 11000078 11000114 11000067 11000050 11000084 11000068 11000052 11000057 11000055 11000070 11000088 11000023 11000061 11000060 11000095 11000094 11000102 11000054 11340004 11000091 11000083 11000098 11000063 11000013 11000015 11000062 11000035 11000081 11000009 11000017 11000110 11000004 11000008 11000005 11000020 11000011 11000014 11000012 11000019 11000022 11000031 11000024 11000034 11000036 11000028 11000030 11340002 11000042 11000037 11000080 11000079 11000039 11000040 11000069 11000038 11000045 11000086 11000049 11000043 11000048 11000059 11000058 11000097 11000096 11000073 11000074 11000071 11000064 11000075 11340005 11000077 11000076 11000089 11000087 11000085 11000106 11000100 11000093 11000104 11000099 11000103 11000115 11000112 11000109 11000117 11000108 11000118
Other Recalls from Philips North America
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1156-2026 | Class II | Patient Information Center iX; Software Versio... | Dec 22, 2025 |
| Z-1204-2026 | Class II | Evolution Upgrade 1.5T. Product Codes (REF): ... | Dec 3, 2025 |
| Z-1215-2026 | Class II | SmartPath to dStream for 3.0T. Product Code (... | Dec 3, 2025 |
| Z-1207-2026 | Class II | Ingenia 3.0T. Product Code (REF): (1) 781342,... | Dec 3, 2025 |
| Z-1209-2026 | Class II | Ingenia Ambition S. Product Code (REF): 78210... | Dec 3, 2025 |
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.