Recall Z-0841-2018— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0841-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-11

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2018-01-11, terminated 2019-05-20. It names one FDA 510(k) clearance: K133674. Product: IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System. Reason: 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2018-01-11
Terminated: 2019-05-20
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

IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System

Reason for recall

23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.

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