Ingenuity TF PET/CT 882442
Check against the official notice below — it lists the full affected range.
Philips Medical Systems is recalling 28 Ingenuity TF PET/CT systems due to a production defect in the X-Ray Tube that can allow oil to leak from the tube housing. If this leakage occurs, it could pose a risk to patients or users. The affected 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.
The recall affects four specific serial numbers: 2086, 2099, 2095, and 2097. The source document does not specify a remedy or recommended action for consumers who may have been affected by 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. Quantity: 28 total Lot/code info: UDI: (01)00884838059443(21)2086, Serial Number: 2086; UDI: (01)00884838059443(21)2099, Serial Number: 2099; UDI: (01)00884838059443(21)2095, Serial Number: 2095; UDI: (01)00884838059443(21)2097, Serial Number: 2097
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.