# FDA recall Z-2735-2017

> **AGFA Healthcare Corp.** · Class II · device recall initiated 2016-12-21.

## 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.

## Distribution

AL, AZ, AR, CA, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WV and Canada

## Key facts

- **Recall number:** Z-2735-2017
- **Recalling firm:** AGFA Healthcare Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-12-21
- **Report date:** 2017-07-26
- **Termination date:** 2019-07-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greenville, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2735-2017

## Citation

> AI Analytics. FDA recall Z-2735-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2735-2017. Source: US FDA. Licensed CC0.

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