FDA-Device2025-08-06Class II
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Steris Corporation
Hazard
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.
Sold states
Worldwide - US Nationwide and Puerto Rico and the country of Canada.
Affected count
59 units
Manufactured in
5960 Heisley Rd, Mentor, OH, United States
Products
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2178-2025Don't want to check this manually?
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