CLASS II ONGOING Device recall · Reported 28 Nov 2018 · FDA Enforcement Report
Telligence Nurse Call System recalled by Ascom (US)
Ascom is recalling Telligence Nurse Call System, distributed in 21 states. The recall was initiated on 2 Nov 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0486-2019
- FDA event ID
- 81546
- Recalling firm
- Ascom, Lakewood Ranch, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Nov 2018
- FDA classified
- 20 Nov 2018
- Reported
- 28 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 2 Nov 2018 | Recall initiated by company | |
| 20 Nov 2018 | Classified by FDA | +18 days |
| 28 Nov 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Ascom Telligence Nurse Call System
Where it was distributed
AL, CA, CO, GA, IN, KY, LA, ME, MI, MO, MN, MS, NE, NV, OH, PA, RI, TX UT, VA, WI
AlabamaCaliforniaColoradoGeorgiaIndianaKentuckyLouisianaMaineMichiganMinnesotaMissouriMississippiNebraskaNevadaOhioPennsylvaniaRhode IslandTexasUtahVirginia
Questions about this recall
Why was it 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.
Which lots are affected?
Version 5.0 (Build 5.0.4)
Where was it sold?
AL, CA, CO, GA, IN, KY, LA, ME, MI, MO, MN, MS, NE, NV, OH, PA, RI, TX UT, VA, WI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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