Ingenuity Core128/Elite China 728324
Check against the official notice below — it lists the full affected range.
Philips Medical Systems is recalling Ingenuity Core128/Elite China X-Ray Tubes due to a production defect that allows oil to leak from the tube housing. If this leakage were to recur, it could pose a risk to patients or users. The affected tubes have the following serial numbers: 336849, 336850, 336851, 336852, 336853, 336854, 336855, and 336856.
These systems were distributed to Hawaii, Kansas, and Missouri in the United States, as well as to Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda internationally. The source record does not specify what action affected consumers should take in response to this recall.
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. Lot/code info: UDI: (01)00884838059863(21)336856, Serial Number: 336856; UDI: (01)00884838059863(21)336851, Serial Number: 336851; UDI: (01)00884838059863(21)336849, Serial Number: 336849; UDI: (01)00884838059863(21)336852, Serial Number: 336852; UDI: (01)00884838059863(21)336853, Serial Number: 336853; UDI: (01)00884838059863(21)336855, Serial Number: 336855; UDI: (01)00884838059863(21)336854, Serial Number: 336854; UDI: (01)00884838059863(21)336850, Serial Number: 336850
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.