FDA Device recall Z-1391-2019
AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a…
- FDA Device
- Class II
- terminated
- Published 2019-05-29
On 2019-05-29 the FDA classified a Class II recall of AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a… by Boston Scientific, citing 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) bein….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1391-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-08 |
| Published | 2019-05-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 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
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.
Identifiers
| code_info | Serial Number: 21302770 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1391-2019%22
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