Recall Z-1061-2017— Philips Electronics North America Corporation

Name: FDA recall Z-1061-2017
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 Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane). 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 Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)

Reason for recall

System may lock up.

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