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

Recall Z-0475-2013 — Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics

U.S. FDA — Device Enforcement · United States · 2012-10-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0475-2013
Date of alert
2012-10-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Healthcare Inc.
Product category
device
Product type
Devices
Reported risk: With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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