Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0486-2019Class II

Ascom Telligence Nurse Call System

Ascom (US) Inc. / initiated 2018-11-02 / Open, Classified / root cause: software

Ascom (US) Inc. began a recall of Ascom Telligence Nurse Call System on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number
Z-0486-2019
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Ascom (US) Inc.
Product
Ascom Telligence Nurse Call System
Product code
IQA System, Environmental Control, Powered
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.
Root cause tag
software
FDA root cause
Software Manufacturing/Software Deployment
Action
Ascom Partners / Distributors were contacted by e-Mail, USPS Mail and Phone as necessary on 11/02/2018 to determine where the Telligence 5.0 Product is installed.
Quantity in commerce
57 units
Distribution
AL, CA, CO, GA, IN, KY, LA, ME, MI, MO, MN, MS, NE, NV, OH, PA, RI, TX UT, VA, WI
Product codes and lots
Version 5.0 (Build 5.0.4)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0486-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0486-2019Class IIOngoingVoluntary: Firm initiated