NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoom
Summary
The FDA issued a Class II for NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, a by Hamamatsu Corporation. Reason: 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..
Details
Source
Device Recall
External ID
Z-2280-2023
Action Date
2023-08-09
Status
Ongoing
Category
device
Product Description
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 Number: C13220-01MD
Lot/Code Info: UDI-DI: 010458238901065911220 S/N: 90121100033
Quantity Affected: 1 unit
Reason for Recall
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.
Distribution
NY
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-06
Company
Bridgewater, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 202 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hamamatsu Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hamamatsu Corporation have FDA actions?
This is the only FDA action we have on record for Hamamatsu Corporation in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2280-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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