Company: Capsule Technologi
Date of Enforcement Report 8/3/11
Class ll:
PRODUCT
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. Recall # Z-2403-2011.
REASON
Software: Data cached on the Neuron due to server unavailability is not being delivered to the server after server availability is restored. If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes. Batteries can discharge completely in a Capsule Neuron” UMPC even though it is connected to power source.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Capsule Tech Inc., Andover MA, by telephone, and email on March 23, and by letter on April 23, 2010.
Manufacturer: Capsule Technologi, Paris, France. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3144 units
DISTRIBUTION
Nationwide and Canada
