Z-2275-2018 Class II Terminated
FDA device recall Z-2275-2018 was initiated by Philips Medical Systems (Cleveland) Inc on Mar 28, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 21, 2020). Affected quantity: 28 total.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 4, 2018
- Initiation Date
- Mar 28, 2018
- Termination Date
- Apr 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 total
Product Description
Ingenuity Core128 728323
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)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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2275-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026