Recall Z-2377-2012— Capsule Tech Inc.

Name: FDA recall Z-2377-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-10

Class II · Terminated

Class II FDA medical device recall by Capsule Tech Inc., initiated 2012-08-10, terminated 2015-04-22. It names 4 FDA 510(k) clearances: K113835, K032142, K020197 and 1 more. 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.. Reason: Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron.

Recalling firm: Capsule Tech Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-08-10
Terminated: 2015-04-22
Firm location: Andover, MA, United States

510(k) clearances named in this recall

4 on FDA's record

K113835 — DATACAPTOR SYSTEMCapsule Tech, Inc.·cleared 2012-06-27
K032142 — DATACAPTORCapsule Technologie·cleared 2003-08-08
K020197 — MODIFICATION TO DATACAPTORCapsule Technologie·cleared 2002-02-21
K013019 — DATACAPTORCapsule Technologie·cleared 2001-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.