Recall Z-1062-2017— Philips Electronics North America Corporation

Name: FDA recall Z-1062-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-09

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2016-12-09, terminated 2020-07-30. It names 2 FDA 510(k) clearances: K041949, K033737. Product: Velara Generator with an old Firmware version used with the Philips Integris BH5000. Reason: System may lock up..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-12-09
Terminated: 2020-07-30
Firm location: Andover, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K041949 — ALLURA XPER FD10Philips Medical Systems North America Co.·cleared 2004-07-30
K033737 — ALLURA XPER FD20Philips Medical Systems North America, Inc.·cleared 2003-12-09

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

Velara Generator with an old Firmware version used with the Philips Integris BH5000

Reason for recall

System may lock up.

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