Z-0283-2016 Class II Terminated
FDA device recall Z-0283-2016 was initiated by AGFA Healthcare Corp. on Sep 1, 2015 and is designated Class II. Reason for recall: Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct. The recall status is terminated (terminated Dec 15, 2020). Affected quantity: 19.
Recall details
- Product Type
- Devices
- Report Date
- Nov 25, 2015
- Initiation Date
- Sep 1, 2015
- Termination Date
- Dec 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19
Product description
IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
Reason for recall
Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct.
Distribution pattern
Distributed in the states of CA, KY, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA and the country of Canada.
Code information
Model # L9M2100
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0283-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026