Recall Z-0450-2015— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0450-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-04

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2014-11-04, terminated 2018-07-02. It names 2 FDA 510(k) clearances: K080927, K062298. Product: BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454. Reason: Software issues.

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2014-11-04
Terminated: 2018-07-02
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K080927 — BRIGHTVIEW VCT IMAGING SYSTEMPhilips Medical Systems (Cleveland), Inc.·cleared 2008-04-11
K062298 — APOLLO GAMMA CAMERA SYSTEMAdac Laboratories·cleared 2006-08-23

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 product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454

Reason for recall

Software issues

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