Drager PT4000 Phototherapy System

• • Terminated Z-1950-2012 FDA Class II ·initiated 2 Jul 2012

  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

510(k) Number

K954611 ↗

FDA Product Code

LBI

Device Class

Class II

Regulation

21 CFR Part 880.5700

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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