Recall Z-2156-2012— Philips Healthcare Inc.

Name: FDA recall Z-2156-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-11

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-07-11, terminated 2013-03-26. It names one FDA 510(k) clearance: K050151. Product: Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System. Reason: When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired..

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-11
Terminated: 2013-03-26
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K050151 — MULTIDIAGNOST ELEVAPhilips Medical Systems North America, Inc.·cleared 2005-02-09

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

Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System

Reason for recall

When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.

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