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U.S. Department of Health and Human Services

Class 2 Device Recall Ascom Telligence Nurse Call System

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  Class 2 Device Recall Ascom Telligence Nurse Call System see related information
Date Initiated by Firm November 02, 2018
Create Date November 20, 2018
Recall Status1 Open3, Classified
Recall Number Z-0486-2019
Recall Event ID 81546
Product Classification System, environmental control, powered - Product Code IQA
Product Ascom Telligence Nurse Call System
Code Information Version 5.0 (Build 5.0.4)
Recalling Firm/
Manufacturer		 Ascom (US) Inc.
9024 Town Center Parkway
Lakewood Ranch FL 34202-4159
For Additional Information Contact David Foth
941-684-5493
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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