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.
FDA Recall Z-2377-2012 · Posted 2012-09-13
Advertisement
Recalling FirmCapsule Tech Inc.
Recall StatusTerminated
Product CodeMWI
Date Initiated2012-08-10
Date Terminated2015-04-22
Product Quantity12,448 units
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
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Denmark, France, Germany, Netherlands and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement