Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MAC 5 A4 Resting ECG Analysis System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall MAC 5 A4 Resting ECG Analysis Systemsee related information
Date Initiated by FirmApril 21, 2026
Date PostedJune 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2306-2026
Recall Event ID 98917
510(K)NumberK221321 
Product Classification Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
ProductMAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Code Information Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124
FEI Number 3003513129
Recalling Firm/
Manufacturer		 GE Medical Systems China Co., Ltd.
No. 19 Changjiang Road
Development Zone National Hi-Tech Xin District
Wuxi China
For Additional Information ContactGE HealthCare Service
800-4371171
Manufacturer 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.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionFirm 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 Commerce16
DistributionWorldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DXH
-
-