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Recall Observatory FDA recall evidence

Device 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 hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers

Z-2213-2013

May 10, 2013

Class II

Product summary

Firm
Rauland-Borg Corp
Event
Event 65657
Status
Terminated
Classification
Class II
Quantity
Product Code 351000: 385 units; Product Codes 352000 and 352020: 14,808 units (total)
Official record key
device-enforcement:Z-2213-2013

Official wording

Reason: 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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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