Recall Z-0970-2013— AGFA Corp.
Class II · Terminated
Class II FDA medical device recall by AGFA Corp., initiated 2013-02-07, terminated 2013-06-06. It names one FDA 510(k) clearance: K121948. Product: 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.. Reason: The cassettes were shipped with the wrong IP (image plate) size bar code..
- Recalling firm
- AGFA Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-07
- Terminated
- 2013-06-06
- Firm location
- Greenville, SC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The cassettes were shipped with the wrong IP (image plate) size bar code.
Data sourced from openFDA. This site is unofficial and independent of the FDA.