Recall Z-0548-2016— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0548-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-29

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2015-10-29, terminated 2018-06-26. It names one FDA 510(k) clearance: K033326. Product: Ingenuity Core 128 Computed Tomography X-ray system. Reason: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2015-10-29
Terminated: 2018-06-26
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K033326 — PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEMPhilips Medical Systems, Inc.·cleared 2003-10-29

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

Ingenuity Core 128 Computed Tomography X-ray system

Reason for recall

Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.

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