Z-0486-2019 Class II Ongoing
FDA device recall Z-0486-2019 was initiated by Ascom (US) Inc. on November 2, 2018 and is designated Class II. 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 Gatewa… The recall status is ongoing. Affected quantity: 57 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2018
- Initiation Date
- November 2, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57 units
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.
Distribution Pattern
AL, CA, CO, GA, IN, KY, LA, ME, MI, MO, MN, MS, NE, NV, OH, PA, RI, TX UT, VA, WI
Code Information
Version 5.0 (Build 5.0.4)