[Recalled] Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems — The DFPM yoke assembly ("yoke assembly") may detach from the spring arm | FDA 2025-06-23
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems |
|---|---|
| Brand / manufacturer | Steris Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2178-2025 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 23 June 2025 |
| EAN / barcode | 00724995171155 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Steris Corporation
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.