Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Reported: August 6, 2025 Initiated: June 23, 2025 #Z-2178-2025
Product Description
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.
Details
- Recalling Firm
- Steris Corporation
- Units Affected
- 59 units
- Distribution
- Worldwide - US Nationwide and Puerto Rico and the country of Canada.
- Location
- Mentor, OH
Frequently Asked Questions
What product was recalled? ▼
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems. Recalled by Steris Corporation. Units affected: 59 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 6, 2025. Severity: Moderate. Recall number: Z-2178-2025.
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