NanoZoomer S360MD Slide Scanner May Record Incorrect Barcode Information
Hamamatsu's NanoZoomer S360MD slide scanner may record incorrect barcode information in the NDPi file, potentially causing pathologists to reference the wrong patient's digital slide image.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a risk-of-harm medical device with potential for serious patient misidentification through incorrect barcode recording. No illnesses, injuries, or adverse patient outcomes have been reported to date.
Plain-English summary
The NanoZoomer S360MD is an automated system for creating, viewing, and managing digital images of tissue slides. According to this FDA Class II recall notice, if the wrong barcode information is recorded in the NDPi file, a pathologist may inadvertently refer to the whole slide image (WSI) of a different patient instead of the intended patient.
This recall affects systems distributed to New York. Affected users include pathology laboratories, hospitals, and other medical facilities operating the NanoZoomer S360MD (Catalog Number C13220-01MD). If you operate this equipment, review your barcode entry procedures and verify that the correct patient data is being referenced when reviewing diagnostic slides.
The recalled product
- 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
- Manufacturer
- Hamamatsu Corporation
- Affected units
- 1
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)
- UDI-DI: 010458238901065911220 S/N: 90121100033
Distribution
Distributed in 1 state:
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