FDA Device

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

Hazard

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

What You Should Do

Remedy

Tech Bulletins sent a letter dated May 10, 2013, to all affected customers notifying them of the counterfeit parts and requesting that customers uninstall and return affected products to Rauland-Borg for replacement. A subsequent recall notification letter dated August 5, 2013 was mailed to customers. The letter included instructions to both direct accounts and end users on the process of replacing affected units with units manufactured with authentic parts. For additional information please call 847-590-5920.

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Products

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, tr
Brand
Rauland-Borg Corp
UPC
1) Product Code 351000 (Branch Regional Controller);  2) Product Code 352000 (Corridor Light);  3) Product Code 352020 (Domeless Controller)

Units Affected

Product Code 351000: 385 units; Product Codes 352000 and 352020: 14,808 units (total)

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