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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98917

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

Open FDA event record

Event summary

Timeline bucket
April 21, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
GE Medical Systems China Co., Ltd.

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

MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

Z-2306-2026
Recall number
Z-2306-2026
Initiated
April 21, 2026
Classification
Class II
Status
Ongoing
Quantity
16

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software in development inadvertently made available for customer use. Use of this software version can result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.

Code information

Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124

Distribution pattern

Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.

Field note

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