Company: Philips Medical Systems, Inc.
Date of Enforcement Report 3/22/2017
Class lI:
PRODUCT
882480: BrightView 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). .
Recall Number Z-1480-2017
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/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 1/31/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1218 total
DISTRIBUTION
Nationwide and Internationally
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