FDAFDA · Food and drugs·Recall number Z-0970-2013
CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.
Published March 27, 2013 · Recall initiated: February 7, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The cassettes were shipped with the wrong IP (image plate) size bar code.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- AGFA Corp.
- Distributor
- USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.
- Lot
- Batch No. A2KQMW
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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