Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Capsule Neuron UMPC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Capsule Neuron UMPC see related information
Date Initiated by Firm August 25, 2010
Date Posted June 01, 2011
Recall Status1 Terminated 3 on March 20, 2012
Recall Number Z-2403-2011
Recall Event ID 58636
510(K)Number K013019  K020197  K032142  
Product Classification Monitor, physiological, patient (with arrhythmia detection or alarms - Product Code MWI
Product Capsule Neuron UMPC is a component in the DataCaptor" Connectivity System.
Catalog Number: DC-NU-MPC

Capsule Neuron" UMPC is a bedside device that enables automatic collection of vital signs data that can local cache data and connect to the hospital network through a wired
Ethernet connection or via a standard 802.11 b/g/n wireless network, available in a fixed or mobile mounting option, running either DataCaptor continuous or periodic connectivity software

The DataCaptor" System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor" is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to
Code Information Serial Numbers: TS9800281 - TS9801370 TS9900645 - TS9900654 TS9B00103 - TS9B01109 TSA300737 - TSA301336 TSA600927 - TSA601526 TSA800623 - TSA801221 TSAA00335 - TSAA00338 TSAB01605 - TSAB02204 TSB300957 - TSB301460
Recalling Firm/
Manufacturer		 Capsule Tech Inc.
300 Brickstone Sq
Andover MA 01810-1492
For Additional Information Contact SAME
978-482-2309
Manufacturer Reason
for Recall		 Software: Data cached on the Neuron due to server unavailability is not being delivered to the server after server availability is restored. If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes. Batteries can discharge completely in a Capsule Neuron" UMPC even though it is connected to power source
FDA Determined
Cause 2		 Software design
Action Capsule Tech initiated three corrective action notifications for the Neuron" UMPC units three failure modes as follows: a) Data cached on the Capsule Neuron" UMPC due to server unavailability is not being delivered to the server after server availability is restored: i) A customer advisory was provided to a subset of consignees, along with DataCaptor software version 6.6.5 on December 1, 2010. ii) A customer advisory was provided to the remaining consignees, along with DataCaptor software version 6.6.7 on January 27, 2011. If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes: i) A customer advisory was provided to all consignees on March 23, 2011, via phone call, email and FedEx;.The correction will be provided as a software update. A formal recall notification letter will be provided to all consignees alerting them to the availability of the correction once it is released, via phone call, email and FedEx. c) Batteries can discharge completely in a Capsule Neuron" UMPC even though it is connected to power. Note: the Capsule Neuron" UMPC operates normally when connected to power. i) A customer advisory was provided to all consignees on April 23, 2010, via FedEx. For questions regarding this recall contact Capsule technical support team at (800) 260-9537 or e-mail support@capsuletech.com..
Quantity in Commerce 3,144 Capsule Neuron UMPC units
Distribution Worldwide Distribution - USA (nationwide) and the country of Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = CAPSULE TECHNOLOGIE
-
-