Recall Z-2377-2012 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Capsule Tech Inc.
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 netwo
| Date | Sep 13, 2012 (initiated Aug 10, 2012) |
| Status | Terminated |
| Reason | Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron |
| 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 | 12,448 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Denmark, France, Germany, Netherlands and UK. |
| FDA record | Open on fda.gov |