Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2213-2013Class II

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

Rauland-Borg Corporation / initiated 2013-05-10 / Terminated

Rauland-Borg Corp began a recall of 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... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2213-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Rauland-Borg Corporation
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
Product code
ILQ System, Communication, Powered
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
FDA root cause
Counterfeit
Action
Tech Bulletins sent a letter dated May 10, 2013, to all affected customers notifying them of the counterfeit parts and requesting that customers uninstall and return affected products to Rauland-Borg for replacement. A subsequent recall notification letter dated August 5, 2013 was mailed to customers. The letter included instructions to both direct accounts and end users on the process of replacing affected units with units manufactured with authentic parts. For additional information please call 847-590-5920.
Quantity in commerce
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.
Product codes and lots
1) Product Code 351000 (Branch Regional Controller);  2) Product Code 352000 (Corridor Light);  3) Product Code 352020 (Domeless Controller)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2213-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2213-2013Class IITerminatedVoluntary: Firm initiated