FDA Medical Device Recalls (openFDA)
Omnyx Llc: Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.
- Recall number
- Z-0469-2014
- Recalling firm
- Omnyx Llc
- Product
- Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.
- Status
- Terminated
- Initiated
- 2013-10-01
- Posted
- 2013-12-09
- Terminated
- 2014-04-16
- Reason
- 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.
- Root cause
- Software design
- Action
- Omnyx sent a Urgent Field Safety Notice letter dated October 1, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Please discontinue use of the measurement and area calculation features of the annotation tools (line, rectangle/square, ellipse/circle, and freeform) in the DPS Image Viewer at this time. If any of these tools have been used for measurements or area calculations on clinical cases, verify measurements and calculations on glass slides. Please confirm receipt of these instructions by completing the attached form and scanning/emailing it to FieldAction@ omnyx.com or faxing it to 001-412-894-2137 Product Correction: An updated version of the DPS SW will be released and installed on your system as soon as it becomes available. Please note that the appropriate regulatory authorities have been informed of this field action. We apologize for any inconvenience that this may have caused you and are working diligently to address this issue. If you have any additional questions or concerns, please contact you GE Healthcare account representative. Further questions please call (412) 891-2100.
- Quantity
- 2
- Distribution
- International Distribution to Canada and Switzerland only.
- Lot, serial or model codes
- catalog # OMN-1005056-1, K1600LH, DPS 1.1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OTU
- Firm FEI
- 3008491142
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28