AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated… — Class II medical device recall Z-1698-2017
Terminated recall by AGFA Healthcare Corp., reported 2017-04-05, distributed in AL, AR, CA, CO, DC, FL, GA, IA…. The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an
| Recall number | Z-1698-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGFA Healthcare Corp., Greenville, SC, United States |
| Recall initiated | 2016-01-20 |
| Classified | 2017-03-29 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2017-04-10 |
| Distributed | AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, RI, SC, TN, TX, VA, WI, WV, WY |
| Countries outside the US | CA |
| Quantity | 308 |
Product
AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
Reason for recall
The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1698-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.