FDA Device recall Z-2620-2024
Aurora 3 Series, Aurora 7 lighthead
- FDA Device
- Class II
- ongoing
- Published 2024-08-21
On 2024-08-21 the FDA classified a Class II recall of Aurora 3 Series, Aurora 7 lighthead by Dkk Dai Ichi Shomei, citing the weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2620-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-09 |
| Published | 2024-08-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Dkk Dai Ichi Shomei |
| Distribution | US |
Product
Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
Reason
The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
Identifiers
| code_info | Model Number: AUT7-LH/TV-LH; Serial Numbers: 13040011, 13040012, 13040013, 13040014, 13040015, 13040016, 13040017, 1304…Model Number: AUT7-LH/TV-LH; Serial Numbers: 13040011, 13040012, 13040013, 13040014, 13040015, 13040016, 13040017, 13040018, 13040019, 13040020, 13040021, 13040022, 13040023, 13040024, 13070025, 13070026, 13070027, 13070028, 13070029, 13070030, 13070031, 13070032, 13070033, 13070034, 13070035, 13070036, 13070037, 13070038, 13070039, 13070040, 13070041, 13070042, 13070043, 13080044, 13080045, 13080046, 13080047, 13080048, 13080049, 13080050, 13080051, 13080052, 13080053, 13090054, 13090055, 13090056, 13090057, 13090058, 13090059, 13090060, 13090061, 13090062, 13090063, 13090064, 13090065, 13090066, 13090067, 13090068, 13090069, 13090070, 13090071, 13090072, 13090073, 13090074, 13090075, 13090076, 13090077, 13100078, 13100079, 13100080, 13100081, 13100082, 13100083, 13100084, 13100085, 13100086, 13100087, 13100088, 13100089, 13100090, 13100091, 13100092, 13100093, 13100094, 13100095, 13100096, 13100097, 13110098, 13110099, 13110100, 13110101, 13110102, 13110103, 13110104, 13110105, 13110 |
|---|
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-2620-2024%22
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