Z-0118-2027

HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing...

Name: Z-0118-2027 HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing...
Creator: Steris Corporation
Published: 2026-09-23
License: https://open.fda.gov/license/

Steris Corporation / initiated 2026-09-23 / Open, Classified

FDA source

Recall record

Recall number: Z-0118-2027
Status: Open, Classified
Initiated: 2026-09-23
Posted: 2026-10-07
Recalling firm: Steris Corporation
Product: HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18
Product code: FTA Light, Surgical, Accessories
Reason for recall: A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.
FDA root cause: Software design
Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 9/9/26 was sent to customers. User Action Users can continue to use their integration system(s) prior to completion of the correction, but should confirm that manually printed images are correctly labeled prior to clinical use, filing or scanning into a patient record, distribution or other reliance upon the printed output. Customers should consider reviewing any manually printed images generated using software version 2.0.18 if they have reason to believe the manual print workflow described in this notice may have occurred. Prior to your system(s) receiving the updated software, if you are utilizing the manual printing functionality and have questions regarding the issue described in this notice or interim mitigation measures, please contact STERIS ORI Support at [email protected], or at 800-548-4873. Users are reminded to report any adverse events via FDA s MedWatch Database or local competent authority should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers.
Quantity in commerce: 58 systems
Distribution: Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.
Product codes and lots: Lot Code: UDI: 00724995245047; Serial Numbers: RL25293001 RL25301003 RL25301004 RL26007031 RL26013044 RL26013045 RL26028062 RL26040066 RL26054029 RL26062001 RL26063005 RL26063007 RL26063013 RL26063014 RL26063019 RL26063021 RL26063022 RL26063023 RL26069033 RL26069034 RL26072049 RL26072052 RL26072053 RL26072055 RL26072056 RL26072056 RL26077072 RL26077073 RL26077074 RL26083077 RL26084078 RL26084080 RL26084081 RL26085083 RL26085084 RL26085085 RL26085086 RL26085087 RL26085088 RL26085089 RL26089090 RL26089091 RL26089092 RL26089093 RL26089094 RL26089095 RL26089096 RL26089097 RL26098098 RL26104099 RL26105102 RL26133103 RL26133104 RL26138105 RL26139106 RL26140114 RL26187116 RL26243121

Product code FTA

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 2026-10-09. View this recall on fda.gov (opens on fda.gov)