Recall Z-2280-2023— Hamamatsu Corporation
Class II · Ongoing
Class II FDA medical device recall by Hamamatsu Corporation, initiated 2023-06-06. It names one FDA 510(k) clearance: K213883. Product: 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. 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..
- Recalling firm
- Hamamatsu Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-06
- Firm location
- Bridgewater, NJ, 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
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.