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Dual flat panel monitor (dfpm) accessory to the harmonyair® a-series and e-series surgical lighting systems

Official notice

24 Jun 2025

MediumHealth Canada

An official Health Canada notice concerns Dual flat panel monitor (dfpm) accessory to the harmonyair® a-series and e-series surgical lighting systems. 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 Published 2025-06-24.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77643

Official notice

2025-06-24

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77643

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Affected products

Product 1

Affected products - Dual Flat Panel Monitor (DFPM) Accessory To The HarmonyAIR® A-Series And E-Series Surgical Lighting Systems, Lot or serial number - 0426223004, Model or catalog number - 00013H11L

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Steris, Dual Flat Panel Monitor Accessory To The Harmonyair® A-series And E-series Surgical Lighting.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

77643

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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