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
Reported: April 5, 2017 Initiated: January 20, 2016 #Z-1698-2017
Product Description
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.
Details
- Recalling Firm
- AGFA Healthcare Corp.
- Units Affected
- 308
- Distribution
- Worldwide Distribution - US including AL, AR, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OK, OR, RI, SC, TN, TX, VA, WV, WI, WY, and Internationally to Canada.
- Location
- Greenville, SC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by AGFA Healthcare Corp.. Units affected: 308.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2017. Severity: Moderate. Recall number: Z-1698-2017.
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