||June 01, 2011
||Terminated on March 20, 2012
|Recall Event ID
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) - Product Code MWI
||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
TS9800281 - TS9801370
TS9900645 - TS9900654
TS9B00103 - TS9B01109
TSA300737 - TSA301336
TSA600927 - TSA601526
TSA800623 - TSA801221
TSAA00335 - TSAA00338
TSAB01605 - TSAB02204
TSB300957 - TSB301460
|Capsule Tech Inc.
300 Brickstone Sq
Andover, Massachusetts 01810-1492
|For Additional Information Contact
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
|DESIGN: Software Design
||Capsule Tech initiated three corrective action notifications for the Neuron" UMPC units three failure modes as follows:
a) Data cached on the Capsule Neuron" UMPC due to server unavailability is not being delivered to the server after server availability is restored:
i) A customer advisory was provided to a subset of consignees, along with DataCaptor software version 6.6.5 on December 1, 2010.
ii) A customer advisory was provided to the remaining consignees, along with DataCaptor software version 6.6.7 on January 27, 2011.
If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes:
i) A customer advisory was provided to all consignees on March 23, 2011, via phone call, email and FedEx;.The correction will be provided as a software update. A formal recall notification letter will be provided to all consignees alerting them to the availability of the correction once it is released, via phone call, email and FedEx.
c) Batteries can discharge completely in a Capsule Neuron" UMPC even though it is connected to power. Note: the Capsule Neuron" UMPC operates normally when connected to power.
i) A customer advisory was provided to all consignees on April 23, 2010, via FedEx.
For questions regarding this recall contact Capsule technical support team at
(800) 260-9537 or e-mail firstname.lastname@example.org..
|Quantity in Commerce
||3,144 Capsule Neuron UMPC units
||Worldwide Distribution - USA (nationwide) and the country of Canada
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = MWI and Original Applicant = CAPSULE TECHNOLOGIE