510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Ascom (US) Inc.

Morrisville, NC, US

ASCOM US, INC. appears in FDA device records in Morrisville, NC. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Ascom (US) Inc. in 2011.

Clearances by year, as a table
510(k) clearance decisions for Ascom (US) Inc., by decision year
YearClearances
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K103634ASCOM CLINICALCONNEX CARDIOMAXMSXSubstantially Equivalent

Registered establishments

FDA registered establishments for Ascom (US) Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30088551703008855170ASCOM US, INC.300 Perimeter Park Dr Ste D, Morrisville, NC 27560 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0486-2019Ascom Telligence Nurse Call SystemThere 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.Class IIOpen, Classified
Z-1638-2016Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).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.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain