Reported Aug 20, 2014 · Terminated
DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the…
AGFA Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- DX-D 600 -
- DXD Imaging Package Product UsageIs 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, check abdomen and other both parts
- Lot codes and dates
Serial Nos. A5430000089A5430000131A5430000015A5430000095A5430000052A5430000061A5430000079A5430000030A5430000042A5430000066A5430000081A5430000085A5430000096A5430000020A5430000067A5430000125A5430000105
- Amount recalled
- 17 units
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
Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.
This product could cause temporary or reversible health problems — stop using it.
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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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