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Z-2213-2013 Class II Terminated

Recalled by Rauland-Borg Corp — Mount Prospect, IL

FDA device recall Z-2213-2013 was initiated by Rauland-Borg Corp on May 10, 2013 and is designated Class II. 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 th… The recall status is terminated (terminated May 6, 2015). Affected quantity: Product Code 351000: 385 units; Product Codes 352000 and 352020: 14,808 units (total).

Recall Details

Product Type: Devices
Report Date: September 25, 2013
Initiation Date: May 10, 2013
Termination Date: May 6, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Product Code 351000: 385 units; Product Codes 352000 and 352020: 14,808 units (total)

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

Distribution Pattern

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.

Code Information

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