Recall Z-2735-2016— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2735-2016
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: K062298. Product: BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging. 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

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 X, model #882478; gamma camera designed for single or dual detector nuclear imaging

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.