Z-2277-2018 Class II Terminated
FDA device recall Z-2277-2018 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).
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 Description
Ingenuity Core128/Elite China 728324
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)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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2277-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026