Recall archive / FDA device enforcement
BrightView X, Gamma Camera, Product Code 882478 — FDA record Z-0678-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 30, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- BrightView X, Gamma Camera, Product Code 882478
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Philips North America
- Quantity
- 59 US; 59 OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0678-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 17, 2024
- Recall initiation date
- Nov 30, 2023
- Center classification date
- Jan 5, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.