Recall Z-0333-2018— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0333-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-08

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2017-11-08, terminated 2020-04-17. It names one FDA 510(k) clearance: K133674. Product: Philips Healthcare IQon Spectral CT computed tomography x-ray system. Reason: There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2017-11-08
Terminated: 2020-04-17
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K133674 — PHILIPS IQON SPECTRAL CTPhilips Healthcare (Cleveland)·cleared 2014-11-21

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 Healthcare IQon Spectral CT computed tomography x-ray system

Reason for recall

There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.

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