Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2018 - (Recall #: Z-2277-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Ingenuity Core128/Elite China 728324

Product Classification:

Class II

Date Initiated: March 28, 2018

Date Posted: July 4, 2018

Recall Number: Z-2277-2018

Event ID: 80176

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.

Status: Terminated

Product Quantity:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated