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U.S. Department of Health and Human Services

Class 2 Device Recall CellaVision DM96, DM1200, DM9600 and DI60

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  Class 2 Device Recall CellaVision DM96, DM1200, DM9600 and DI60 see related information
Date Initiated by Firm December 04, 2017
Create Date June 13, 2018
Recall Status1 Open3, Classified
Recall Number Z-2184-2018
Recall Event ID 80137
510(K)Number K033840  K092868  
Product Classification Device, automated cell-locating - Product Code JOY
Product CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60

Product Usage:
The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
Code Information Versions 6.0.1 or 6.0.2
Recalling Firm/
Manufacturer		 Cellavision AB
Forskningsbyn Ideon
Scheelevagen 19a
Lund Sweden
Manufacturer Reason
for Recall		 A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.
FDA Determined
Cause 2		 Software design
Action CellaVision sent an Urgent Medical Device Recall letter dated December 4, 2017. The letter identified affected product, problem and the actions to be taken. Customers are requested to determine if they are affected or not. If affected they are requested to contact their local distributor for installing a patch. Customers are asked to confirm receipt of the notice by signing and dating the attached Acknowledgement Form and emailing a copy to their local distributor. For technical questions contact CelleVision (service@cellavision.se)
Quantity in Commerce Instruments: 224 Software: 99 (US)
Distribution US Nationwide in the states of FL, IL, NY, and NC
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JOY and Original Applicant = CELLAVISION AB
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