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Open, Classified

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

FDA Recall Z-2306-2026 · Posted 2026-06-03

Recalling FirmGE Medical Systems China Co., Ltd.
Recall StatusOpen, Classified
Product CodeDXH
Date Initiated2026-04-21
Product Quantity16

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.

Firm Action

Firm notified consignees beginning April 21, 2026 via letters titled "URGENT MEDICAL DEVICE CORRECTION". Customers were given instructions on how to check their software version. If a customer's software version begins with 3.00, the customer should not use the system until a GE HealthCare representative has updated the device with the latest licensed software version.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K221321MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2022-10-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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