Consumer Alerts TrackerIndependent U.S. recall decision aid
How it works Search recalls
Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jun 10, 2026

MAC 5 A4 Resting ECG Analysis System 855001-001

Full official product description

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

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 1, 2026, 12:43 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

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

Identifiers to compare

  • UDI 00195278276070
  • UDI 00195278276124
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. ElectrocardiographSoftware version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 0019527827612416Z-2306-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

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

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.