Recall Z-2403-2011 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Capsule Tech Inc.
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
| Date | Jun 1, 2011 (initiated Aug 25, 2010) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 |
| Quantity | 3,144 Capsule Neuron UMPC units |
| Distribution | Worldwide Distribution - USA (nationwide) and the country of Canada |
| FDA record | Open on fda.gov |