Recall MonitorHealth Products
Dual Flat Panel Monitor (DFPM) Accessory To The HarmonyAIR® A-Series And E-Series Surgical Lighting Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Dual Flat Panel Monitor (DFPM) Accessory To The HarmonyAIR® A-Series And E-Series Surgical Lighting Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Dual Flat Panel Monitor (DFPM) Accessory To The HarmonyAIR® A-Series And E-Series Surgical Lighting Systems | 0426223004 | 00013H11L |
Issue
Steris identified that the DFPM yoke assembly may detach from the spring arm. Should this occur, the yoke assembly is expected to hang by its wiring rather than fully detach, potentially requiring patient transfer and causing a procedure delay. In addition, the yoke assembly could come in contact with the user or patient during detachment. This could result in an injury. Users are requested to review revised preventive maintenance manual and interval based check list language for the HarmonyAIR® a series surgical lighting system and immediately complete maintenance activities as instructed. Recall start date: June 13, 2025