Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application

FDA Recall Z-1927-2021 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeDQK
Date Initiated2021-04-19
Date Terminated2026-01-14
Product Quantity11,295 devices (5,637 US; 5,658 OUS)

Reason for Recall

If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an Electronic Medical Record (EMR) or a similar system.

Firm Action

The recalling firm issued letters dated 4/19/2021 beginning 4/19/2021. For systems that are on Windows 8.1 and above, the issue will be corrected through a software patch. For the units running on Microsoft Windows Server 2008-R2, Windows XP, and Windows 7, the letter instructs that the devices are not to be networked on these systems and that a software patch cannot be made available to these systems since the operating systems are not supported by Microsoft. A second cover letter and customer notification were issued dated 5/10/2021 updating the second safety instruction regarding the units running on Microsoft Windows Server 2008-R2, Windows XP, and Windows 7 saying that these systems must be rebooted before manually exporting tests.

Root Cause

Software design

Distribution Pattern

Worldwide distribution - US Nationwide. Government/military distribution was also made, and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belgium, Bermuda, Brazil, Brunei Darussalam, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Czechia, Denmark, Estonia, Fiji, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Mexico, Moldova, Myanmar, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.

Official Source

View FDA Recall →

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

↑