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U.S. Department of Health and Human Services

Class 2 Device Recall Responder 5

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 Class 2 Recall
Responder 5
see related information
Date Posted September 17, 2013
Recall Status1 Open
Recall Number Z-2213-2013
Recall Event ID 65657
Product Classification System, Communication, Powered - Product Code ILQ
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
Code Information 1) Product Code 351000 (Branch Regional Controller); 2) Product Code 352000 (Corridor Light); 3) Product Code 352020 (Domeless Controller)
Recalling Firm/
Manufacturer
Rauland-Borg Corp
1802 W Central Rd
Mount Prospect, Illinois 60056-2230
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Donna Djinovich
847-590-5920
Manufacturer 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 Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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