Capsule Neuron UMPC is a component in the DataCaptor" Connectivity System. Catalog Number: DC-NU-MPC Capsule Neuron" UMP
FDA device recall Z-2403-2011 · posted 2011-06-01 · Terminated
Recall details
- Recalling firm
- Capsule Tech Inc.
- 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
- Action taken
- 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..
- Root cause
- Software design
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 3,144 Capsule Neuron UMPC units
- Distribution
- Worldwide Distribution - USA (nationwide) and the country of Canada
- Date initiated
- 2010-08-25
- Date posted
- 2011-06-01
- Date terminated
- 2012-03-20
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATACAPTOR (K032142) | Capsule Technologie | 2003-08-08 |
| MODIFICATION TO DATACAPTOR (K020197) | Capsule Technologie | 2002-02-21 |
| DATACAPTOR (K013019) | Capsule Technologie | 2001-12-18 |