Z-1950-2012 Class II Terminated

Recalled by Draeger Medical Systems, Inc. — Telford, PA

Recall Details

Product Type
Devices
Report Date
July 18, 2012
Initiation Date
July 2, 2012
Termination Date
July 1, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
65

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

Distribution Pattern

Nationwide Distribution-USA (nationwide) and Puerto Rico.

Code Information

Catalog number 2M21700 and serial numbers ASCF-0037 TO ASCF-0061; ASCJ-0037 TO ASCJ-0152; ASCL-0001 TO ASCL-0025; ASCM-0001 TO ASCM-0025; and ASDA-002, 0005, 0006, 0007, 0008, 0009, 0012, 0019, 0025.