[pending] HarmonyAIR A-Series Surgical Lighting System
Pending LLM rewrite. Source: FDA_DEVICE Z-2449-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
The recalled product
- Product
- HarmonyAIR A-Series Surgical Lighting System
- Manufacturer
- Steris Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDIs: 00724995185947
- 00724995186418
- 00724995187156
- 00724995188009
- 00724995188498
- 00724995189198
- 00724995185954
- 00724995186425
- 00724995187170
- 00724995188016 00724995188504
- 00724995189211
- 00724995185961
- 00724995186432
- 00724995187187 00724995188047
- 00724995188535
- 00724995189228
- 00724995185978
- 00724995186548 00724995187217
- 00724995188054
- 00724995188542
Distribution
Distributed nationwide across the United States.
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