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

Recall Z-2200-2015 — Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n.

U.S. FDA — Device Enforcement · United States · 2014-07-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2200-2015
Date of alert
2014-07-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Electronics North America Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
453560446041
Reported risk: Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden ROl.
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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