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Recall Observatory FDA recall evidence

Device 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.

Z-2377-2012

August 10, 2012

Class II

Product summary

Firm
Capsule Tech Inc.
Event
Event 62844
Status
Terminated
Classification
Class II
Quantity
12,448 units
Official record key
device-enforcement:Z-2377-2012

Official wording

Reason: Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron

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

Distribution pattern: Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Denmark, France, Germany, Netherlands and UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron