Z-0469-2014Class II

Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which...

Name: Z-0469-2014 Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which...
Creator: Omnyx Llc
Published: 2013-10-01
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2013-10-01 / Terminated / root cause: software

FDA source

Omnyx Llc began a recall of Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated... on 2013-10-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0469-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-01
Posted: 2013-12-09
Terminated: 2014-04-16
Recalling firm: FUJIFILM Healthcare Americas Corporation
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.
Product code: OTU Research Use Only/Pathology
Reason for recall: 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 tag: software
FDA 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 in commerce: 2
Distribution: International Distribution to Canada and Switzerland only.
Product codes and lots: catalog # OMN-1005056-1, K1600LH, DPS 1.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0469-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0469-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-09

Product code OTU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)