Digital Pathology System recall: Software Issue
Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and…
Why was Digital Pathology System recalled?
There is an issue associated with Digital Pathology System (DPS) Software, in which the annotation tools within the DPS version 1.1 Image Viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain conditions.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
catalog # OMN-1005056-1, K1600LH, DPS 1.1
- Product
- Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and…
- Recalling firm
- Omnyx Llc
- Quantity
- 2
- Distribution
- International Distribution to Canada and Switzerland only.
- Recall date
- December 18, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)