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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0486-2019 | Class II | Ongoing | Voluntary: Firm initiated |
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