Recall Z-2737-2016— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2737-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-25

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2016-05-25, terminated 2018-07-02. It names one FDA 510(k) clearance: K080927. Product: BrightView XCT Upgrade Model 882454. Reason: The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2016-05-25
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 XCT Upgrade Model 882454

Reason for recall

The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.

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