Reported Aug 20, 2014 · Terminated
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality…
AGFA Healthcare Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AGFA Healthcare Corp. · 10 S Academy St · Greenville, SC · 29601-2632
Is this the product you have?
- Agfa Digital Radiography
- X-Ray System DX-D 100 Product UsageIs indicated for use in providing diagnostic quality images to aid the physician with diagnoses
- Lot codes and dates
- Serial Number A5410000042
- Amount recalled
- 1
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Unit was mislabeled with a factory label showing 32 KW output power.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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