Recall Z-2223-2012— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2223-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-18

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2012-07-18, terminated 2013-02-22. It names one FDA 510(k) clearance: K033326. Product: The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.. Reason: 1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, which previous versions did. However, the current version does have the Dose Check (NEMA XR-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable Dose Check after ente.

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2012-07-18
Terminated: 2013-02-22
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

The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Reason for recall

1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, which previous versions did. However, the current version does have the Dose Check (NEMA XR-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable Dose Check after ente

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