Recall Z-0486-2019— Ascom (US) Inc.
Class II · Ongoing
Class II FDA medical device recall by Ascom (US) Inc., initiated 2018-11-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Ascom Telligence Nurse Call System. Reason: There is an issue that could cause the Telligence System Gateway II, NGGTWY2 H, to stop communicating to the hallway devices connected to it. When this occurs, the dome lights connected to the Gateway II Ports A and B will start flashing, indicating that they are no longer communicating to the Gateway II. If this occurs, device failures that WOULD otherwise be annunciated WILL NOT be indicated at staff consoles that are configured to display failures..
- Recalling firm
- Ascom (US) Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-11-02
- Firm location
- Lakewood Ranch, FL, United States
Product description
Ascom Telligence Nurse Call System
Reason for recall
There is an issue that could cause the Telligence System Gateway II, NGGTWY2 H, to stop communicating to the hallway devices connected to it. When this occurs, the dome lights connected to the Gateway II Ports A and B will start flashing, indicating that they are no longer communicating to the Gateway II. If this occurs, device failures that WOULD otherwise be annunciated WILL NOT be indicated at staff consoles that are configured to display failures.
Data sourced from openFDA. This site is unofficial and independent of the FDA.