Reported Aug 9, 2023 · Ongoing

NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The…

Hamamatsu Corporation

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: Hamamatsu Corporation · 360 Foothill Rd · Bridgewater, NJ · 08807-2920

Is this the product you have?

  • NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded (FFPE) tissue
  • Catalog NumberC13220-01MD
Lot codes and dates
  • UDI-DI010458238901065911220
  • S/N90121100033
Amount recalled
1 unit

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 PM UTC

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