Recall Z-0431-2014— Philips Medical Systems, Inc.

Name: FDA recall Z-0431-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-30

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2013-10-30, terminated 2017-01-09. It names one FDA 510(k) clearance: K031535. Product: Easy Diagnost Eleva Universal Fluoroscopic applications. Reason: The delivered application software was an outdated version to the model of equipment..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-30
Terminated: 2017-01-09
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K031535 — PHILIPS EASYDIAGNOST ELEVAPhilips Medical Systems North America Co.·cleared 2003-06-17

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

Easy Diagnost Eleva Universal Fluoroscopic applications

Reason for recall

The delivered application software was an outdated version to the model of equipment.

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