Philips Ingenuity Core 728321
Check against the official notice below — it lists the full affected range.
Philips Medical Systems is recalling 28 Ingenuity Core 728321 X-Ray Tube units due to a production defect that allows oil to leak from the tube housing. If this leakage recurs, 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 five specific units identified by serial numbers 333169, 310377, 310375, 333171, and 333172. The source document 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. Quantity: 28 total Lot/code info: UDI: (01)00884838059498(21)333169, Serial Number: 333169; UDI: (01)00884838059498(21)310377, Serial Number: 310377; UDI: (01)00884838059498(21)310375, Serial Number: 310375; UDI: (01)00884838059498(21)333171, Serial Number: 333171; UDI: (01)00884838059498(21)333172, Serial Number: 333172
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.