Reported Sep 25, 2013 · Terminated

Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system…

Rauland-Borg Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Rauland-Borg Corp · 1802 W Central Rd · Mount Prospect, IL · 60056-2230

Is this the product you have?

  • 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
Lot codes and dates
  • 1) Product Code 351000 (Branch Regional Controller); 2) Product Code 352000 (Corridor Light); 3) Product Code 352020 (Domeless Controller)
Amount recalled
Product Code 351000: 385 units; Product Codes 352000 and 352020: 14,808 units (total)

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 6, 2015 · Data as of Sep 19, 4:51 PM UTC

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