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U.S. Department of Health and Human Services

Class 2 Device Recall NanoZoomer S360MD Slide scanner System

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 Class 2 Device Recall NanoZoomer S360MD Slide scanner Systemsee related information
Date Initiated by FirmJune 06, 2023
Date PostedAugust 01, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2280-2023
Recall Event ID 92627
510(K)NumberK213883 
Product Classification Whole slide imaging system - Product Code PSY
ProductNanoZoomer 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
Code Information UDI-DI: 010458238901065911220 S/N: 90121100033
Recalling Firm/
Manufacturer		 Hamamatsu Corporation
360 Foothill Rd
Bridgewater NJ 08807-2920
For Additional Information ContactSAME
908-356-1203
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionHamamatsu Corporation issued Urgent: Medical Device Correction Letter via Email on 6/6/23. Letter states reason for recall, health risk and action to take: The risk of recurrence will be fully eliminated by conducting the NZAcquire software update on the user PCs either by a Field Service Engineer being on site or via a remote control. As a precautionary measure, there are two kinds of risk mitigations in place to reduce the potential serious risk. 1. There is a clear note in the NZAcquireMD Reference manual regarding the barcode information. 2. There is a warning in the system manual that the intended use of WSI generated out of the system is designed to provide information as an aid for a diagnosis among other information. 2. There is a warning in the system manual that the intended use of WSI generated out of the system is designed to provide information as an aid for a diagnosis among other information available. In other words, medical decisions should not be made exclusively based on the data from the device. Provide the contact information of the appropriate person with whom we can arrange a time to complete this service. Please provide the following information for the contact person by emailing us at: nanozoomerqanotifications@hamamatsu.com The affected users will perform one temporary measure to the software settings
Quantity in Commerce1 unit
DistributionNY
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PSY
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