Z-2274-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 4, 2018
- Initiation Date
- March 28, 2018
- Termination Date
- April 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 total
Product Description
Philips Ingenuity Core 728321
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 Pattern
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.
Code Information
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