Recall Z-0118-2027 ยท FTA Light, Surgical, Accessories
Steris Corporation
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
| Date | Oct 7, 2026 (initiated Sep 23, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| 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 |
| Quantity | 58 systems |
| Distribution | Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.