FDA Device recall Z-2178-2025
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems by Steris, citing 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 deta….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2178-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-23 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Steris |
| Distribution | US |
Product
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
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.
Identifiers
| code_info | UDI: 00724995171155: Serial numbers: 0416920048, 0417820084, 0417820088, 0417820096, 0417820110, 0417820092, 041782010…UDI: 00724995171155: Serial numbers: 0416920048, 0417820084, 0417820088, 0417820096, 0417820110, 0417820092, 0417820100, 0418420047, 0419620004, 0419520013, 0428620109, 0428620112, 0430020191, 0431720044, 0435120043, 0435120047, 0435120051, 0401321042, 0413221047, 0413221199, 0413721008, 0413721012, 0417221023, 0417221027, 0417221031, 0420021018, 0420021022, 0420021026, 0420721021, 0429720003, 0420921073, 0426321186, 0426321190, 0427121121, 0427121125, 0427321012, 0427321002, 0427321005, 0413921017, 0434121095, 0434121098, 0434121101, 0434121104, 0434121107, 0434121110, 0434121113, 0400722081, 0406022021, 0406022025, 0406022034, 0406022038, 0406022017, 0406022014, 0406022011, 0417122078, 0417122081, 0417122084, 0417122087, 0417122090. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2178-2025%22
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