Recall Z-1461-2014— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1461-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-27

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2014-03-27, terminated 2016-02-02. It names 4 FDA 510(k) clearances: K060937, K033357, K033326 and 1 more. Product: Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.. Reason: Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table tops subframe..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2014-03-27
Terminated: 2016-02-02
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

4 on FDA's record

K060937 — BRILLIANCE VOLUMEPhilips Medical Systems (Cleveland), Inc.·cleared 2006-06-05
K033357 — ACQSIM-MULTISLICE-CT, MODEL 453567042271Philips Medical Systems (Cleveland), Inc.·cleared 2004-01-09
K033326 — PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEMPhilips Medical Systems, Inc.·cleared 2003-10-29
K012009 — MX8000 IDT CT SYSTEMMarconi Medical Systems, Inc.·cleared 2001-09-13

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 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.

Reason for recall

Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table tops subframe.

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