Z-2377-2012Class II

Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK...

Name: Z-2377-2012 Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK...
Creator: Capsule Tech Inc.
Published: 2012-08-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-08-10 / Terminated / root cause: design

FDA source

Capsule Tech Inc. began a recall of 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... on 2012-08-10. FDA classified it as Class II and gives the reason as "Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2377-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-10
Posted: 2012-09-13
Terminated: 2015-04-22
Recalling firm: Philips North America LLC
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.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 12,448 units
Distribution: Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Denmark, France, Germany, Netherlands and UK.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2377-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2377-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-13

Product code MWI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)