Agfa Digital Radiography X-Ray System DX-D 100 recallZ-2176-2014 · AGFA Healthcare Corp. · initiated May 13, 2014
Class III Terminated All recalls posted in August 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from AGFA Healthcare Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Unit was mislabeled with a factory label showing 32 KW output power.
FDA root cause category: Labeling mix-ups
What the company is doing
Only one customer was affected no customer letter was issued field correction was conducted..
Recall details
- Recall number
- Z-2176-2014
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- May 13, 2014
- Posted by the FDA
- Aug 10, 2014
- Recalling firm
- AGFA Healthcare Corp.
- Quantity
- 1
- Product code
- IZL
- FDA submissions
- K103597
- Distribution
- US in the state of WV
Product description
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
Code information (models, lots, serial numbers)
Serial Number A5410000042
Other devices under the same FDA submission
1 device cleared under K103597 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DX-D 100 5411/050Agfa · System, x-ray, mobile2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page