Z-1775-2021 Class II Terminated
FDA device recall Z-1775-2021 was initiated by Fujifilm Medical Systems U.S.A., Inc. on April 30, 2021 and is designated Class II. Reason for recall: Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does … The recall status is terminated (terminated July 29, 2024). Affected quantity: 44 US and 4 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- June 9, 2021
- Initiation Date
- April 30, 2021
- Termination Date
- July 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 US and 4 OUS
Product Description
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Reason for Recall
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center.
Code Information
Software Versions: 6.0 to 6.2.1