FDAClass IISeptember 25, 2013

Responder 5 is a nurse call communication system that recall

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…

Why was Responder 5 is a nurse call communication system that 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Rauland-Borg Corp
Quantity
Product Code 351000: 385 units; Product Codes 352000 and 352020: 14,808 units (total)
Distribution
Worldwide distribution - US: (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NE, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and WV., and the countries of : Australia, Canada, Columbia, Lebanon, Mexico and Saudi Arabia.
Recall date
September 25, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls