Recall Z-1588-2013— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1588-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-21

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2013-03-21, terminated 2013-11-27. It names one FDA 510(k) clearance: K033326. Product: Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.. Reason: If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bol.

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2013-03-21
Terminated: 2013-11-27
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

Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.

Reason for recall

If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bol

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