Z-1927-2021 Class II Terminated
FDA device recall Z-1927-2021 was initiated by GE Healthcare, LLC on April 19, 2021 and is designated Class II. 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… The recall status is terminated (terminated January 14, 2026). Affected quantity: 11,295 devices (5,637 US; 5,658 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- June 30, 2021
- Initiation Date
- April 19, 2021
- Termination Date
- January 14, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,295 devices (5,637 US; 5,658 OUS)
Product Description
Reason for Recall
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.