Recall Z-1187-2017— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1187-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-23

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2016-12-23, terminated 2018-07-02. It names one FDA 510(k) clearance: K080927. Product: BrightView X upgraded to XCT 882454. Reason: The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2016-12-23
Terminated: 2018-07-02
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K080927 — BRIGHTVIEW VCT IMAGING SYSTEMPhilips Medical Systems (Cleveland), Inc.·cleared 2008-04-11

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

BrightView X upgraded to XCT 882454

Reason for recall

The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.

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