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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73578

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 10, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ascom US, INC.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).

Z-1638-2016
Recall number
Z-1638-2016
Initiated
December 10, 2015
Classification
Class II
Status
Terminated
Recalling firm
Ascom US, INC.
Quantity
319

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
malfunction of software

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Ascom Mobile Monitoring Gateway version 4.1.1 & 4.2.0 and Ascom Unite Connect for Nurse Call version 2.2.0

Distribution pattern

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.