Z-2306-2026Class II

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

Name: Z-2306-2026 MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001...
Creator: GE Medical Systems China Co., Ltd.
Published: 2026-04-21
License: https://open.fda.gov/license/

GE Medical Systems China Co., Ltd. / initiated 2026-04-21 / Open, Classified / root cause: software

FDA source

GE Medical Systems China Co., Ltd. began a recall of MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph on 2026-04-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2306-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-21
Posted: 2026-06-03
Recalling firm: GE Medical Systems China Co., Ltd.
Product: MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Product code: DXH Transmitters And Receivers, Electrocardiograph, Telephone
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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
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.
Quantity in commerce: 16
Distribution: Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
Product codes and lots: Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2306-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2306-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-03

Product code DXH

K221321Class IIMAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. / cleared 2022-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)