Lower riskMedical device recall · FDA · Published September 23, 2026
Steris HexaVue Focus Integration System Software Issue May Cause Patient Info Mismatch
Steris recalls 58 HexaVue Focus Integration Systems with software version 2.0.18 and specific serial numbers due to risk of incorrect patient information appearing on printed images.
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.
“Steris HexaVue Focus Integration System Software Issue May Cause Patient Info Mismatch.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1629437-steris-corporation-recalls-hexavue-focus-integration-system-a-single-all. Based on FDA recall #Z-0118-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0118-2027%22&limit=1).
The FDA announced on September 23, 2026, that Steris Corporation is recalling the HexaVue Focus Integration System due to a software issue. The hazard involves unintended mismatch of patient information on manually printed images.
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.
Context
GovInfoNow's records show Steris Corporation has 31 other recalls on record since June 15, 2017. Other recent recalls include the VERIFY Dual Species Self-Contained Biological Indicator (August 31, 2026), Steris HarmonyAIR A-Series Surgical Lights (May 15, 2026), and a Steris Corporation recall regarding paint delamination (May 15, 2026). Other recent recalls of similar products include Philips IntraSight Plus Software Error May Cause Wrong Patient Diagnosis (August 6, 2026) and GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software Recall: Patient Data Mismatch Risk (July 31, 2026).
How to tell if you have this one
Check for software version 2.0.18 and specific serial numbers listed in the recall notice. The systems were sold worldwide, including the US, Australia, Canada, and New Zealand.
Brand
Steris
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version is 2.0.18 by checking the system's settings.
Identify Serial Numbers
Look for the serial numbers listed in the recall notice to confirm if your system is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 21 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0118-2027 (September 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0118-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.