FDAFDA · Food and drugs·Recall number Z-1950-2012
Drager PT 4000 Phototherapy System
Published July 18, 2012 · Recall initiated: July 2, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Draeger Medical Systems, Inc.
- Distributor
- Nationwide Distribution-USA (nationwide) and Puerto Rico.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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