Recall Z-0406-2016— Philips Electronics North America Corporation

Name: FDA recall Z-0406-2016
Creator: U.S. Food and Drug Administration
Published: 2015-04-14

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-04-14, terminated 2020-09-23. It names one FDA 510(k) clearance: K033326. Product: Philips Healthcare Ingenuity Core Computed Tomography X-ray system. Reason: During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-04-14
Terminated: 2020-09-23
Firm location: Andover, MA, 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

Philips Healthcare Ingenuity Core Computed Tomography X-ray system

Reason for recall

During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.

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