Z-1662-2014 Class II Terminated
FDA device recall Z-1662-2014 was initiated by AGFA Corp. on April 30, 2014 and is designated Class II. Reason for recall: Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service. The recall status is terminated (terminated September 18, 2014). Affected quantity: One.
Recall Details
- Product Type
- Devices
- Report Date
- June 4, 2014
- Initiation Date
- April 30, 2014
- Termination Date
- September 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- One
Product Description
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
Reason for Recall
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
Distribution Pattern
Distribution to SC only
Code Information
Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - OCR Service