High FDA (Devices)·Z-2377-2012·Announced 2012-09-19

Capsule Neuron Docking Station Recalled for Potential Connection Loss

Capsule Tech Inc. is recalling 12,448 Capsule Neuron Docking Stations because they may lose connection, causing data loss or power interruption to the bedside device.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Capsule Tech Inc. is recalling 12,448 units of the Capsule Neuron Docking Station, a component of the DataCaptor Connectivity System. The affected units are identified by specific serial numbers listed in the recall notice. The product is a bedside device that enables the automatic collection of vital signs data and connects to hospital networks via wired Ethernet or wireless networks.

The recall was initiated because the Capsule Neuron Docking Station may experience a lost connection. This malfunction can result in the loss of data or the loss of power to the Capsule Neuron device. The agency has classified this recall as Class II.

The affected units were distributed worldwide, including nationwide in the United States and in Belgium, Canada, Denmark, France, Germany, the Netherlands, and the United Kingdom. Users should contact Capsule Tech Inc. for instructions on how to address the issue.

The recalled product

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
Manufacturer: Capsule Tech Inc.
Category: Medical Device — Vital Signs Monitoring
Hazard: data-loss
power-loss
Affected units: 12,448

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

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