Recall Z-1120-2015— Philips Medical Systems, Inc.

Name: FDA recall Z-1120-2015
Creator: U.S. Food and Drug Administration
Published: 2014-06-06

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-06-06, terminated 2021-10-15. It names one FDA 510(k) clearance: K102005. Product: Philips Medical System Allura Xper X-Ray Angiographic. Reason: In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-06
Terminated: 2021-10-15
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K102005 — ALLURA XPER OR TABLE SERIESPhilips Medical Systems North America, Inc.·cleared 2010-08-09

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 Medical System Allura Xper X-Ray Angiographic

Reason for recall

In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.

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