Recall Z-0022-2015— Philips Medical Systems, Inc.

Name: FDA recall Z-0022-2015
Creator: U.S. Food and Drug Administration
Published: 2014-08-08

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-08-08, terminated 2014-12-03. It names one FDA 510(k) clearance: K002016. Product: Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system. Reason: Philips had discovered through a field service testing where a device failed to comply with a Federal standard..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-08-08
Terminated: 2014-12-03
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K002016 — PHILIPS INTEGRIS ALLURAPhilips Medical Systems North America, Inc.·cleared 2000-09-06

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 Healthcare Integris Allura 15 -12 Fluoroscopy x ray system

Reason for recall

Philips had discovered through a field service testing where a device failed to comply with a Federal standard.

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