Recall Z-2177-2025 ยท FSY Light, Surgical, Ceiling Mounted
Steris Corporation
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
| Date | Jul 25, 2025 (initiated Jun 23, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 a |
| Quantity | 167 units |
| Distribution | Worldwide - US Nationwide and Puerto Rico and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.