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Devices
TCm monitoring system
Model / Serial
TCM4 - Base Unit : Model: 391-876, Lot Numbrs R0036 thru R0043 (both inclusive). CompactFlash cards - Component: Model #914-698
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide-The recalled product was distributed to customers throughout the U.S. and Canada.
Product Description
TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)
Manufacturer
Radiometer America Inc
1 Event
Recall of TCm monitoring system
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Manufacturer
Radiometer America Inc
Manufacturer Address
Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
Source
USFDA
Language
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