Z-1391-2019Class II

AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0

Name: Z-1391-2019 AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0
Creator: Boston Scientific Corporation
Published: 2019-04-08
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2019-04-08 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a 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 fiber optic... on 2019-04-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1391-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-08
Posted: 2019-05-22
Terminated: 2023-05-10
Recalling firm: Boston Scientific Corporation
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.
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: Boston Scientific issued to the user level the correction/removal via a customer notification letter via FedEx or hand delivery by a Boston Scientific agent on 4/9/19. Letter provides recommendations to the user until a field repair can be completed or a replacement console can be provided. A Boston Scientific representative will be in contact with you directly to schedule a field repair or replacement at your facility. The console can continue to be used during this time following the recommendations within the letter.
Quantity in commerce: 1 (OUS)
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
Product codes and lots: Serial Number: 21302770

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1391-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1391-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1392-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1393-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1394-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1395-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1396-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1397-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1398-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1399-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22

Product code GEX

K111475Class IIAuriga XlStarmedtec GmbH / cleared 2011-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)