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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73601

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

Open FDA event record

Event summary

Timeline bucket
November 18, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Radiometer America 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

TCM CombiM Modules 903-111

Z-1595-2016
Recall number
Z-1595-2016
Initiated
November 18, 2015
Classification
Class II
Status
Terminated
Recalling firm
Radiometer America Inc
Quantity
1488

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.

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

Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.

Code information

Part Number: 903-111 Lot Number: Below R0174

Distribution pattern

Worldwide Distribution - USA (nationwide) Distribution to the states of : MO, NE, AL, PA, IL, MN, TX, ID, CO, UT, NV, CA, NY, RI, OR, NJ, AZ, GA, IN, VA, LA, NM, MD and AR., and to the countries of : Canada, Austria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, United Kingdom, Italy, Netherlands, Norway, Spain, Sweden, United Arab Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Croatia, Malta, Iceland, Brazil, Thailand, Philippines, Peru, Honduras, Mexico, Kenya, Israel, Romania, Russia, Poland, Turkey, Australia, New Zealand, China, Hong Kong, South Africa, India, Korea, Singapore and Taiwan.

Field note

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