FDA-Device2012-07-18Class II
Drager PT 4000 Phototherapy System
Draeger Medical Systems, Inc.
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
Sold states
Nationwide Distribution-USA (nationwide) and Puerto Rico.
Affected count
65
Manufactured in
3135 Quarry Rd, Telford, PA, United States
Products
Drager PT 4000 Phototherapy System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1950-2012Don't want to check this manually?
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