Drager PT 4000 Phototherapy System
- Company
- Draeger Medical Systems, Inc.
- Recall Initiated
- July 2, 2012
- Posted
- July 6, 2012
- Terminated
- July 1, 2013
- Recall Number
- Z-1950-2012
- Quantity
- 65
- Firm Location
- Telford, PA
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
Nationwide Distribution-USA (nationwide) and Puerto Rico.
Lot / Code Info
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.
Root Cause
Other
Action Taken
Drager Medical Systems sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 2012 to all affected customers. The letter identifies the product, problem, and actions to bee taken by the customers. In addition, a Customer Reply Card was included for customers to complete and return. Contact the firm at 800-543-5047 for questions regarding this recall.