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

FDA device recall Z-2377-2012 · posted 2012-09-13 · Terminated

Recall details

Recalling firm

Capsule Tech Inc.

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

MWI

Quantity affected

12,448 units

Distribution

Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Denmark, France, Germany, Netherlands and UK.

Date initiated

2012-08-10

Date posted

2012-09-13

Date terminated

2015-04-22

Location

Andover, MA

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