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Devices
Device Recall Drager PT 4000 Phototherapy System
Model / Serial
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.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution-USA (nationwide) and Puerto Rico.
Product Description
Drager PT 4000 Phototherapy System
Manufacturer
Draeger Medical Systems, Inc.
1 Event
Recall of Device Recall Drager PT 4000 Phototherapy System
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Manufacturer
Draeger Medical Systems, Inc.
Manufacturer Address
Draeger Medical Systems, Inc., 3135 Quarry Rd, Telford PA 18969-1042
Manufacturer Parent Company (2017)
Stefan Dräger GmbH
Source
USFDA
Language
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