PlainRecalls
FDA Devices Moderate Class II Terminated

Philips Ingenuity Core 728321

Reported: July 4, 2018 Initiated: March 28, 2018 #Z-2274-2018

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.

Details

Units Affected
28 total
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.
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled?
Philips Ingenuity Core 728321. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 28 total.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 4, 2018. Severity: Moderate. Recall number: Z-2274-2018.