Recall Z-2306-2026— GE Medical Systems China Co., Ltd.

Name: FDA recall Z-2306-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-21

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems China Co., Ltd., initiated 2026-04-21. It names one FDA 510(k) clearance: K221321. Product: MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph. Reason: 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..

Recalling firm: GE Medical Systems China Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2026-04-21
Firm location: Wuxi, China

510(k) clearances named in this recall

1 on FDA's record

K221321 — MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.·cleared 2022-10-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.