Recall Z-2678-2014— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2678-2014
Creator: U.S. Food and Drug Administration
Published: 2007-01-09

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2007-01-09, terminated 2015-11-06. It names one FDA 510(k) clearance: K033357. Product: No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.. Reason: When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2007-01-09
Terminated: 2015-11-06
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K033357 — ACQSIM-MULTISLICE-CT, MODEL 453567042271Philips Medical Systems (Cleveland), Inc.·cleared 2004-01-09

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

No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.

Reason for recall

When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.

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