Hamamatsu recalls NanoZoomer S360MD slide scanners due to risk of pathologists using wrong patient images from misrecorded barcodes. Affected units have specific catalog numbers and serial numbers.
If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient.
Hamamatsu is recalling its NanoZoomer S360MD slide scanners because misrecorded barcode information could lead pathologists to view the wrong patient's digital slides. This could cause serious errors in medical diagnosis if not corrected.
The scanner system records barcodes to link digital slides to patients. If the wrong barcode is entered into the NDPi file, the system might display a different patient's entire slide image during diagnosis. This could lead to misdiagnosis if the pathologist uses the incorrect patient's images.
Pathologists and medical labs using the NanoZoomer S360MD slide scanners are most at risk. The recall affects specific units with catalog number C13220-01MD and serial numbers starting with 90121100033.
Check for catalog number C13220-01MD and serial numbers starting with 90121100033 on the scanner. The product was sold with specific model details as listed in the recall notice.
Check the catalog number (C13220-01MD) and serial number (starting with 90121100033) on your scanner.
The recall is due to a risk that pathologists might view the wrong patient's digital slides if the scanner records incorrect barcode information in the NDPi file.
Check the catalog number and serial number on your scanner. If it matches the recalled units, you should verify the scanner's details to ensure proper use.
The recall record does not mention a specific fix or remedy for this issue.
We’ve drafted a message you can send Hamamatsu to request your refund or repair — edit it as you like.
Subject: Recall Z-2280-2023 — Hamamatsu Hamamatsu Hello, I own a Hamamatsu that is covered by recall Z-2280-2023 from Hamamatsu. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
