# FDA recall Z-3245-2018

> **Agfa N.V.** · Class II · device recall initiated 2018-08-15.

## Product

DX-D 600    Product Usage:  The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

## Reason for recall

A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others.

## Distribution

Worldwide Distribution - US Nationwide in the states of  CA, DC, FL, IL, IN, KS, LA, MA, MN, MO, NV, NY, OH, OR, SC and TN. Foreign distribution to Canada.

## Key facts

- **Recall number:** Z-3245-2018
- **Recalling firm:** Agfa N.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-15
- **Report date:** 2018-10-03
- **Termination date:** 2020-06-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mortsel, Belgium

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3245-2018

## Citation

> AI Analytics. FDA recall Z-3245-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-3245-2018. Source: US FDA. Licensed CC0.

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