Recall Z-1021-2016— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1021-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-17

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2015-12-17, terminated 2018-07-02. It names one FDA 510(k) clearance: K062298. Product: BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.. Reason: The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause.

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2015-12-17
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 are gamma cameras; Designed for single or dual detector nuclear imaging.

Reason for recall

The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause

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