FDAFDA · Food and drugs·Recall number Z-2273-2018
Brilliance Big Bore Radiology 728244
Published July 4, 2018 · Recall initiated: March 28, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.
- Lot
- UDI: (01)00884838059450(21)76064, Serial Number: 76064; UDI: (01)00884838059450(21)76102, Serial Number: 76102; UDI: (01)00884838059450(21)76094, Serial Number: 76094
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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