Recall Z-2709-2014— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2709-2014
Creator: U.S. Food and Drug Administration
Published: 2005-12-27

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2005-12-27, terminated 2015-11-06. It names 2 FDA 510(k) clearances: K033326, K010817. Product: Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.. Reason: The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2005-12-27
Terminated: 2015-11-06
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K033326 — PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEMPhilips Medical Systems, Inc.·cleared 2003-10-29
K010817 — MX8000 V5.0 CT SYSTEMPhilips Medical Systems (Cleveland), Inc.·cleared 2001-06-15

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 System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.

Reason for recall

The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.

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