Medical device recalls Moderate risk

Ascom (US) Inc. recalls Ascom Telligence Nurse Call System

Recall date
November 2, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0486-2019
FDA classification
Class II
Brand / firm
Ascom (US) Inc.
Sold / distributed
AL, CA, CO, GA, IN, KY, LA, ME, MI, MO, MN, MS, NE, NV, OH, PA, RI, TX UT, VA, WI

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ascom Telligence Nurse Call System

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