# FDA recall Z-1393-2019

> **Boston Scientific Corporation** · Class II · device recall initiated 2019-04-08.

## 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.

## Distribution

Worldwide distribution to Australia, Belgium, Brazil, Chile, Colombia, Egypt, France, Germany, Great Britain, India, Indonesia, Iran, Italy, Lebanon, Malaysia, Mexico, Romania, Russia Fed., South Africa, South Korea, Spain, Taiwan, United Arab Emirates and Vietnam

## Key facts

- **Recall number:** Z-1393-2019
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-08
- **Report date:** 2019-05-29
- **Termination date:** 2023-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1393-2019

## Citation

> AI Analytics. FDA recall Z-1393-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1393-2019. Source: US FDA. Licensed CC0.

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