Recall Z-1142-2019— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1142-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-03

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2018-07-03, terminated 2020-04-17. It names one FDA 510(k) clearance: K012009. Product: Brilliance 16 Air, 728246 Product Usage: 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: Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2018-07-03
Terminated: 2020-04-17
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

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 16 Air, 728246 Product Usage: 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

Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.

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