Recall Z-2213-2013— Rauland-Borg Corp
Class II · Terminated
Class II FDA medical device recall by Rauland-Borg Corp, initiated 2013-05-10, terminated 2015-05-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers. Reason: A counterfeited electronic component was identified in the products affected. The component, a data transceiver (transmitter/receiver), is associated with the intercommunication of these devices in the Responder 5 system across the L-Net data path. Failure of a data transceiver results in the loss of nurse call functionality in the associated room, and may disrupt communications on the L-Net run.
- Recalling firm
- Rauland-Borg Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-10
- Terminated
- 2015-05-06
- Firm location
- Mount Prospect, IL, United States
Product description
Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers
Reason for recall
A counterfeited electronic component was identified in the products affected. The component, a data transceiver (transmitter/receiver), is associated with the intercommunication of these devices in the Responder 5 system across the L-Net data path. Failure of a data transceiver results in the loss of nurse call functionality in the associated room, and may disrupt communications on the L-Net run
Data sourced from openFDA. This site is unofficial and independent of the FDA.