Agfa Healthcare NX 3 — Class II medical device recall Z-2735-2017
Terminated recall by AGFA Healthcare Corp., reported 2017-07-26, distributed in AL, AR, AZ, CA, DC, FL, GA, IL…. A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting
| Recall number | Z-2735-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGFA Healthcare Corp., Greenville, SC, United States |
| Recall initiated | 2016-12-21 |
| Classified | 2017-07-14 |
| Reported by FDA | 2017-07-26 |
| Terminated | 2019-07-10 |
| Distributed | AL, AR, AZ, CA, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WV |
| Countries outside the US | CA |
| Quantity | 221 units |
| Reason classes | software |
Product
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Reason for recall
A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2735-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.