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

Recall Z-0884-2013 — Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system

U.S. FDA — Device Enforcement · United States · 2012-10-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0884-2013
Date of alert
2012-10-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Healthcare Inc.
Product category
device
Product type
Devices
Reported risk: When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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