Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems

FDA device recall Z-2177-2025 · posted 2025-07-25 · Open, Classified

Recall details

Recalling firm

Steris Corporation

Reason for recall

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.

Action taken

Steris issued an URGENT MEDICAL DEVICE RECALL NOTICE dated 06/17/2025 to its consignees on 06/23/2025 disseminated via FedEx. The notice explained the issue, potential risk, and requested the following: User Action: Please ensure the following steps are completed: 1. Review the revised Preventive Maintenance Manual and Interval Based Check List language depending on which HarmonyAIR Surgical Lighting System model(s) are in use at your facility (A-Series and/or E-Series) (please reference Attachments B-E of the letter for maintenance instructions). 2. Immediately complete the maintenance activities as instructed, and then again annually going forward. 3. Complete the Medical Device Recall Response Form included with this letter. 4. Return the completed Response Form via email to: Regulatory_Compliance@STERIS.com, or via fax to 440-392-8963. 5. Distributors: If you have further distributed this product, please identify your Customer(s), and notify them of this recall.

Root cause

Process control

Status

Open, Classified

Product code

FSY

Quantity affected

167 units

Distribution

Worldwide - US Nationwide and Puerto Rico and the country of Canada.

Date initiated

2025-06-23

Date posted

2025-07-25

Location

Mentor, OH