Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95837

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

Open FDA event record

Event summary

Timeline bucket
December 18, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Braemar Manufacturing, LLC

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

Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.

Z-0708-2025
Recall number
Z-0708-2025
Initiated
December 18, 2024
Classification
Class I
Status
Ongoing
Quantity
~130,000 with 41,282 customers (1 software copy used)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.

Code information

Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4

Distribution pattern

US Nationwide distribution including PR.