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Draeger Medical Systems, Inc. recalls Drager PT 4000 Phototherapy System
Recalled July 18, 2012 · FDA recall Z-1950-2012 · Draeger Medical Systems
Hazard
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 · FDA Class II
Units
65
Sold at
Nationwide Distribution-USA (nationwide) and Puerto Rico.
Description
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
Product
Drager PT 4000 Phototherapy System
Manufacturer(s)
Draeger Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →