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

Recall Z-1021-2016 — BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.

U.S. FDA — Device Enforcement · United States · 2015-12-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1021-2016
Date of alert
2015-12-17
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)
11000003
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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