The Recall Desk
HighFDA (Devices)·Z-2213-2013·Announced 2013-09-25

Rauland-Borg Recalls Responder 5 Nurse Call Systems Due to Counterfeit Parts

Rauland-Borg is recalling Responder 5 nurse call systems because counterfeit electronic components may cause the devices to lose communication functionality.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where failure results in the loss of nurse call functionality, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Rauland-Borg Corp is recalling the Responder 5 nurse call communication system. This system is used in hospitals and long-term patient care facilities to connect patients with staff and to facilitate communication between various departments such as radiology, physical therapy, and transport.

The recall is being conducted because a counterfeited electronic component, specifically a data transceiver, was identified in the affected products. This component is associated with the intercommunication of devices across the L-Net data path. If the data transceiver fails, it results in the loss of nurse call functionality in the associated room and may disrupt communications on the L-Net run.

The affected units include Product Code 351000 (Branch Regional Controller), Product Code 352000 (Corridor Light), and Product Code 352020 (Domeless Controller). The distribution was worldwide, including the United States and several international countries. Healthcare facilities should contact Rauland-Borg Corp for instructions on how to address the affected units.

The recalled product

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 hospital
Manufacturer
Rauland-Borg Corp
Category
Medical Device — Nurse Call System
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • 1) Product Code 351000 (Branch Regional Controller)
  • 2) Product Code 352000 (Corridor Light)
  • 3) Product Code 352020 (Domeless Controller)

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Related recalls

Same hazard · loss of function

See all →