Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1480-2017 — 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-programme

U.S. FDA — Device Enforcement · United States · 2017-01-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1480-2017
Date of alert
2017-01-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems (Cleveland) Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
40007030003
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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