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Rauland-Borg Corporation

Mount Prospect, IL, US

RAULAND-BORG CORPORATION appears in FDA device records in Mount Prospect, IL. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for Rauland-Borg Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10002271511000227151RAULAND-BORG CORPORATION1802 West Central Road, Mount Prospect, IL 60056 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2213-2013Responder 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 providersA 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 runClass IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain