# FDA recall Z-1462-2024

> **Agfa N.V.** · Class II · device recall initiated 2024-02-23.

## Product

Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients.     Models: 5411/ 050, A5411/ 0300 and A5411/ 0400

## Reason for recall

Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Argentina,  Australia, Austria, Belgium, Chile, China, Colombia, Czech Republic, Finland, France,  Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Mexico, New Zealand, Norway,  Peru, Poland, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden,  Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-1462-2024
- **Recalling firm:** Agfa N.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-23
- **Report date:** 2024-04-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1462-2024

## Citation

> AI Analytics. FDA recall Z-1462-2024. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-1462-2024. Source: US FDA. Licensed CC0.

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