Surgical Lighting Accessory Yoke Assembly May Detach from Spring Arm
Steris is recalling 167 DFPM yoke assembly units for HarmonyAIR A-Series Surgical Lighting Systems. The yoke assembly may detach from the spring arm and hang from internal wiring.
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: This FDA Class II medical device recall involves a potential detachment hazard in surgical lighting equipment. No illnesses or injuries have been reported. The risk of equipment malfunction in a surgical setting where precision is critical qualifies this as a High severity recall per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Steris Corporation is recalling 167 units of Dual Flat Panel Monitor (DFPM) yoke assembly accessories for HarmonyAIR A-Series Surgical Lighting Systems. The affected units were distributed in the United States, Puerto Rico, and Canada.
The yoke assembly may detach from the spring arm. If detachment occurs, the assembly would not fully separate but would remain suspended by the wiring within the yoke assembly.
Users of these surgical lighting systems should be aware of this defect and contact Steris Corporation for further guidance regarding their equipment.
The recalled product
- Product
- Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
- Manufacturer
- Steris Corporation
- Hazard
- equipment-malfunction
- detachment-hazard
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)
- UDI: 00724995203245: Serial Numbers: 0400224028
- 0401625167
- 0401625171
- 0401625180
- 0401625185
- 0401625190
- 0402022165
- 0402022169
- 0402422003
- 0402622007
- 0402925148
- 0403122053
- 0403122057
- 0403125009
- 0403223079
- 0403223083
- 0403223087
- 0403223091
- 0403321066
- 0403321070
Distribution
Distributed nationwide across the United States.
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