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

Recall Z-1950-2012 — Drager PT 4000 Phototherapy System

U.S. FDA — Device Enforcement · United States · 2012-07-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1950-2012
Date of alert
2012-07-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Draeger Medical Systems, Inc.
Product category
device
Product type
Devices
Reported risk: A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. The possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat. There have not b
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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