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Ascom US, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 3008855170

Devices
1
Registrations
FDA
FDA recalls
20 ongoing since 2021 (1 open in total)
1 open since before 2021

Catalogue1

Newest first, rows 1-1 of 1

Company details

FDA FEI number
3008855170
Address
300 Perimeter Park Dr Ste D, Morrisville, NC, 27560

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 1
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

1 initiated before 2017

  • 2018

    • 2 Nov 2018 Z-0486-2019 Class II Open since 2018 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: AL, CA, CO, GA, IN, KY, LA, ME, MI, MO, MN, MS, NE, NV, OH, PA, RI, TX UT, VA, WI

  • 2015

    • 10 Dec 2015 Z-1638-2016 Class II Terminated Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. Messages from GE Carescape/Nurse Call will not forward to handset until primary module is restored. Distribution: CA, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI and Hawaii. Australia,…
      Full distribution text CA, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI and Hawaii. Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Poland, Qatar, Sweden, Switzerland, and United Arab Emirates.
      Submission number: K111215

Frequently asked questions

How many devices does ASCOM US, INC. have in the registry?

The registry currently lists 1 device for ASCOM US, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list ASCOM US, INC.'s devices?

Among its 1 most recently registered device, ASCOM US, INC. has devices listed in FDA 510(k) (1 device).

What risk classes do ASCOM US, INC.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for ASCOM US, INC.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for ASCOM US, INC.?

FDA recall records list 2 recalls initiated by ASCOM US, INC., the most recent initiated on 2 Nov 2018. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from ASCOM US, INC. in the registry?

The most recently registered devices listed for ASCOM US, INC. include ASCOM CLINICALCONNEX CARDIOMAX.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.