Recall Z-1481-2017— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1481-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-31

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2017-01-31, terminated 2018-07-02. It names 2 FDA 510(k) clearances: K080927, K062298. Product: 882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).. Reason: Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan.

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2017-01-31
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

882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

Reason for recall

Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

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