Agfa X-Ray Image Plate Recall Due to Incorrect Barcode Labeling
Agfa Corp. is recalling 17 X-ray image plates shipped with incorrect size barcodes, affecting facilities in 10 US states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation and labeling error (incorrect barcode) with no reported injuries or adverse health consequences, fitting the criteria for a Low severity recall.
Plain-English summary
Agfa Corp. is recalling 17 units of the CR MD1.0 General Set, x-ray imager image plate (CR 10-X Image Plate 35CM X 43CM). These image plates are contained in X-Ray cassettes and are used to capture images from X-Ray exposures. The recalled units are identified by Batch No. A2KQMW.
The recall was initiated because the cassettes were shipped with the wrong image plate (IP) size bar code. This labeling error could potentially affect the processing or identification of the image plates within the Agfa Digitizer CR 10-X system.
The affected products were distributed nationwide in the United States, specifically in the states of Alabama, California, Florida, Indiana, Minnesota, Nebraska, Nevada, Ohio, South Carolina, and Utah. Healthcare facilities that received these specific image plates should stop using them and contact Agfa Corp. for further instructions.
The recalled product
- 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…
- Manufacturer
- AGFA Corp.
- Hazard
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch No. A2KQMW
Distribution
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