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FDA (Device enforcement)Recalled 2018-03-28closedclass ii

Philips Medical Systems (Cleveland) Inc: Brilliance Big Bore Radiology 728244

Is my product affected?

Brilliance Big Bore Radiology 728244

  • UPC 00884838059450

Check against the official notice below — it lists the full affected range.

What happened

Philips Medical Systems is recalling 28 Brilliance Big Bore Radiology X-Ray Tubes due to a production defect that allows oil to leak from the tube housing. This oil leakage could pose a risk to patients or users if it were to occur. The affected tubes were distributed to hospitals and medical facilities in Hawaii, Kansas, and Missouri in the United States, as well as to facilities in Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.

The recall affects three specific tubes with serial numbers 76064, 76102, and 76094. The source document does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 28 total Lot/code info: UDI: (01)00884838059450(21)76064, Serial Number: 76064; UDI: (01)00884838059450(21)76102, Serial Number: 76102; UDI: (01)00884838059450(21)76094, Serial Number: 76094

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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