Z-2652-2017 Class II Terminated
FDA device recall Z-2652-2017 was initiated by AGFA Healthcare Corp. on Dec 22, 2016 and is designated Class II. Reason for recall: A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm. The recall status is terminated (terminated Aug 27, 2021). Affected quantity: 10.
Recall details
- Product Type
- Devices
- Report Date
- Jul 5, 2017
- Initiation Date
- Dec 22, 2016
- Termination Date
- Aug 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product description
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
Reason for recall
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
Distribution pattern
Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI
Code information
Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2652-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026