CLASS II Device recall · Reported 19 Sep 2012 · FDA Enforcement Report
Capsule Neuron Docking Station, a component recalled by Capsule Tech
Capsule Tech is recalling Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System, distributed nationwide in the US. The recall was initiated on 10 Aug 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2377-2012
- FDA event ID
- 62844
- Recalling firm
- Capsule Tech, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2012
- FDA classified
- 13 Sep 2012
- Reported
- 19 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Aug 2012 | Recall initiated by company | |
| 13 Sep 2012 | Classified by FDA | +34 days |
| 19 Sep 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Denmark, France, Germany, Netherlands and UK.
Questions about this recall
Is Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System recalled?
Yes. Capsule Tech recalled Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System on 10 Aug 2012. The recall is Class II and its status is Terminated. Recall number Z-2377-2012.
Why was it recalled?
Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron
Which lots are affected?
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
Where was it sold?
Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Denmark, France, Germany, Netherlands and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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