AGFA Digital Radiography X-Ray System DX-D 100 recallZ-1487-2013 · AGFA Corp. · initiated May 15, 2013
Class II Terminated All recalls posted in June 2013
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 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
Customers could potentially experience intermittent, unintended and illogical movement when using the product.
FDA root cause category: Under Investigation by firm
What the company is doing
Agfa sent an "URGENT SAFETY NOTICE" letter dated May 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed if you experience unintended movement, the unit has to be taken out of operation. Please notify you Agfa service contact at once. Please distribute this information within your facility to all those who need to be aware of this. Please complete the feedback form as soon as possible and return to us. For further questions please call 1-877-777-2432.
Recall details
- Recall number
- Z-1487-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 15, 2013
- Posted by the FDA
- Jun 6, 2013
- Recalling firm
- AGFA Corp.
- Quantity
- 104
- Product code
- IZL
- FDA submissions
- K103597
- Distribution
- Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada
Product description
AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.
Code information (models, lots, serial numbers)
Material numbers in US - 5Q82F, 5R75Q, 5Q8ZB, 5R77U & 58Q1D - Material numbers in Canada - 5R78W & 5R77U
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.
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