Draeger Medical Systems, Inc.: Medical Device Recall in 2012 - (Recall #: Z-1950-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Drager PT 4000 Phototherapy System

Product Classification:

Class II

Date Initiated: July 2, 2012

Date Posted: July 18, 2012

Recall Number: Z-1950-2012

Event ID: 62470

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

Status: Terminated

Product Quantity: 65

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.

Distribution Pattern:

Nationwide Distribution-USA (nationwide) and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated