AURIGA XL 4007 GENERAL — Class II medical device recall Z-1393-2019
Terminated recall by Boston Scientific Corporation, reported 2019-05-29. Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mecha
| Recall number | Z-1393-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2019-04-08 |
| Classified | 2019-05-22 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2023-05-10 |
| Countries outside the US | AE, AU, BE, BR, CL, CO, DE, EG, ES, FR, GB, ID, IN, IR, IT, KR, LB, MX, MY, RO, RU, TW, VN, ZA |
| Quantity | 3 |
| Reason classes | specification failure |
| Serial numbers | 21302937, 21302938, 21302939 |
Product
AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Reason for recall
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1393-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.