Devices

Device Recall Capsule Neuron UMPC

Model / Serial
Serial Numbers: TS9800281 - TS9801370 TS9900645 - TS9900654 TS9B00103 - TS9B01109 TSA300737 - TSA301336 TSA600927 - TSA601526 TSA800623 - TSA801221 TSAA00335 - TSAA00338 TSAB01605 - TSAB02204 TSB300957 - TSB301460
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the country of Canada
Product Description
Capsule Neuron UMPC is a component in the DataCaptor" Connectivity System. || Catalog Number: DC-NU-MPC || Capsule Neuron" UMPC is a bedside device that enables automatic collection of vital signs data that can local cache data and connect to the hospital network through a wired || Ethernet connection or via a standard 802.11 b/g/n wireless network, available in a fixed or mobile mounting option, running either DataCaptor continuous or periodic connectivity software || The DataCaptor" System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor" is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to
Manufacturer
Capsule Tech Inc.
1 Event
- Recall of Device Recall Capsule Neuron UMPC

Manufacturer

Capsule Tech Inc.

Manufacturer Address
Capsule Tech Inc., 300 Brickstone Sq, Andover MA 01810-1492
Source
USFDA

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