Steris Surgical Lighting Monitor Yoke Assembly May Detach
Steris is recalling DFPM monitor accessories for HarmonyAIR E-Series surgical lighting systems because the yoke assembly may partially detach from the spring arm. Although it would remain suspended by wiring, this could pose safety concerns during surgical procedures.
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 Class II medical device recall presents a risk of equipment malfunction in a critical surgical setting. Although the yoke assembly would remain tethered by internal wiring and no injuries have been reported, partial detachment could compromise monitor stability during surgery.
Plain-English summary
Steris Corporation is recalling Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems, affecting 59 units distributed worldwide to the United States, Puerto Rico, and Canada.
The DFPM yoke assembly may detach from the spring arm. Should this occur, the yoke assembly would not fully separate but would remain suspended from internal wiring within the assembly. This partial detachment could affect the monitor's stability during surgical use.
Hospitals and surgical facilities using HarmonyAIR E-Series systems should check the FDA recall notice for the list of affected serial numbers and determine whether their equipment is involved.
The recalled product
- Product
- Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
- Manufacturer
- Steris Corporation
- Hazard
- equipment-detachment
- structural-failure
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: 00724995171155: Serial numbers: 0416920048
- 0417820084
- 0417820088
- 0417820096
- 0417820110
- 0417820092
- 0417820100
- 0418420047
- 0419620004
- 0419520013
- 0428620109
- 0428620112
- 0430020191
- 0431720044
- 0435120043
- 0435120047
- 0435120051
- 0401321042
- 0413221047
- 0413221199
Distribution
Distributed nationwide across the United States.
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