FDA-Device2026-06-24Class IIPROCESSING DEFECT
Steris HarmonyAIR A-Series Surgical Lighting System recalled for detachable control buttons
What this means
The plus and minus buttons (+/-) on the light heads of Steris HarmonyAIR A-Series Surgical Lighting Systems may detach during use. This could affect the ability to control light intensity in the operating room. No injuries have been reported.
- If you operate this lighting system, inspect the control buttons on the light heads for signs of looseness or damage.
- Contact Steris Corporation for a replacement or repair of affected units.
- Do not use the system if the control buttons are detached or unstable.
The agency's original wording
Hazard
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution.
Affected count
2101 units
Manufactured in
5960 Heisley Rd, Mentor, OH, United States
Products
HarmonyAIR A-Series Surgical Lighting System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2449-2026Want us to check the next one for you?
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