Ingenuity Core128 728323
Check against the official notice below — it lists the full affected range.
Philips Medical Systems (Cleveland) Inc is recalling Ingenuity Core128 728323 X-Ray Tubes due to a production defect that allows oil to leak from the tube housing. This leakage could pose a risk to patients or users if it were to recur. A total of 28 affected tubes were distributed across three U.S. states (Hawaii, Kansas, and Missouri) and twelve foreign countries (Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda).
The recalled tubes can be identified by their serial numbers: 320403, 320405, 320406, 336321, 320411, 336323, 320425, and 320122. The source document does not specify a remedy or recommended action for consumers who may possess affected units.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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)00884838059504(21)320403, Serial Number: 320403; UDI: (01)00884838059504(21)320405, Serial Number: 320405; UDI: (01)00884838059504(21)320406, Serial Number: 320406; UDI: (01)00884838059504(21)336321, Serial Number: 336321; UDI: (01)00884838059504(21)320411, Serial Number: 320411; UDI: (01)00884838059504(21)336323, Serial Number: 336323; UDI: (01)00884838059504(21)320425, Serial Number: 320425; Serial Number: 320122
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.