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U.S. Department of Health and Human Services

Class 2 Device Recall Capsule Neuron Docking Station

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  Class 2 Device Recall Capsule Neuron Docking Station see related information
Date Initiated by Firm August 10, 2012
Date Posted September 13, 2012
Recall Status1 Terminated 3 on April 22, 2015
Recall Number Z-2377-2012
Recall Event ID 62844
510(K)Number K013019  K020197  K032142  K113835  
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
Product Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System
Catalog Number DC-NU-DS-CK

The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron UMPC which is a bedside device that enables automatic collection of vital signs data that can connect to the hospital network through a wired Ethernet connection or via a standard 802.11 b/g/n wireless network.
Code Information Serial Numbers TS9801371 -TS9801650; TS9900670 - TS9900679; TS9B00413 - TS9B00722; TS9B01753 - TS9B02041; TSA301587 - TSA302186; TSA600246 - TSA600845 TSA801222 - TSA801821; TSAB00031 - TSAB00629; TSB300410 - TSB300912; TSB302698 - TSB303201; TSB401570 - TSB402012; TSB500633 - TSB501136; TSB502359 - TSB502861; TSB600767 - TSB601270; TSB700368 - TSB700871; TSB801147 - TSB803555; TSB902081 - TSB902585; TSBA03569 - TSBA03595; TSBB00027 - TSBB00537; TSBC00200 - TSBC01321; TSC100319 - TSC101318; TSC101972 - TSC103113; TSC301294 - TSC301299; TSC301389 - TSC303425; TSC401639 - TSC401995; TSC402020 - TSC402087; TSC402136 - TSC402346
Recalling Firm/
Manufacturer		 Capsule Tech Inc.
300 Brickstone Sq
Suite 203
Andover MA 01810-1492
For Additional Information Contact Peter Kelley
978-482-2309
Manufacturer Reason
for Recall		 Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron
FDA Determined
Cause 2		 Device Design
Action The firm, Capsule Tech, sent a recall letter dated August 10,2012 to its customers. The letter described the product, problem and actions to be taken. Capsule is sending field correction kits to customers with instructions. Capsule's Professional Services team will contact the customers to schedule shipment of their kit. Final shipments of the field correction kits will be completed by Oct 2012. If you have any questions or concerns, contact your professional services representative and/or call in US: 978-482-2340 or France: +33 153-34-14-00.
Quantity in Commerce 12,448 units
Distribution Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Denmark, France, Germany, Netherlands and UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = CAPSULE TECH INC.
510(K)s with Product Code = MWI and Original Applicant = CAPSULE TECHNOLOGIE
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