FDA recall Z-2178-2025

Steris Corporation · Class II · device

Product

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems

Reason for recall

The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.

Distribution

Worldwide - US Nationwide and Puerto Rico and the country of Canada.

Key facts

Status: Ongoing
Initiation date: 2025-06-23
Report date: 2025-08-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2178-2025