Z-0118-2027 Class II Ongoing
FDA device recall Z-0118-2027 was initiated by Steris Corporation on Sep 23, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 58 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 14, 2026
- Initiation Date
- Sep 23, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58 systems
Product Description
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
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.
Distribution Pattern
Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0118-2027
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026