Recall Z-0118-2027
- Recall number
- Z-0118-2027
- Event number
- 99856
- Firm
- Steris Corporation
- Firm FEI
- 1527821
- Product code
- FTA
- Status
- Open, Classified
- Initiated
- 2026-09-23
- Posted
- 2026-10-07
- Root cause
- Software design
- 510(k) numbers
- K890866, K133413, K081698, K871034, K150532, K954940, K020304, K915068, K051505, K993089, K023704, K133554, K112133, K053321, K810292, K935102, K882132, K020640, K894397, K890539, K890867, K142386, K780162, K102791, K901154, K862010
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
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.