Recall Z-2274-2018— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2274-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-28

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2018-03-28, terminated 2020-04-21. It names one FDA 510(k) clearance: K160743. Product: Philips Ingenuity Core 728321. Reason: 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..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2018-03-28
Terminated: 2020-04-21
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K160743 — Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc.·cleared 2016-08-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.