PlainRecalls
FDA Devices Moderate Class II Terminated

Drager PT 4000 Phototherapy System

Reported: July 18, 2012 Initiated: July 2, 2012 #Z-1950-2012

Product Description

Drager PT 4000 Phototherapy System

Reason for Recall

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

Details

Units Affected
65
Distribution
Nationwide Distribution-USA (nationwide) and Puerto Rico.
Location
Telford, PA

Frequently Asked Questions

What product was recalled?
Drager PT 4000 Phototherapy System. Recalled by Draeger Medical Systems, Inc.. Units affected: 65.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on July 18, 2012. Severity: Moderate. Recall number: Z-1950-2012.