Device recall: AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30…
Class II FDA enforcement event 82691. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Boston Scientific Corporation started this device recall on 8 Apr 2019. The firm address in the FDA record is in Marlborough, MA. FDA put the recall in Class II. FDA event 82691 has 9 product records. The first FDA enforcement report date is 29 May 2019. The record gives the status Terminated, with the termination date 10 May 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution to Australia, Belgium, Brazil, Chile, Colombia, Egypt, France, Germany, Great Britain, India, Indonesia, Iran, Italy, Lebanon, Malaysia, Mexico, Romania, Russia Fed., South…
Recalling firm
Boston Scientific Corporation, Marlborough, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
9 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation,… | 1 (OUS) | Class II | Terminated | 29 May 2019 |
| Z-1392-2019 | AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 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,… | 27 (OUS) | Class II | Terminated | 29 May 2019 |
| Z-1393-2019 | 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,… | 3 (OUS) | Class II | Terminated | 29 May 2019 |
| Z-1394-2019 | AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 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,… | 6 (OUS) | Class II | Terminated | 29 May 2019 |
| Z-1395-2019 | AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 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,… | 8 (OUS) | Class II | Terminated | 29 May 2019 |
| Z-1396-2019 | AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 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,… | 3 (OUS) | Class II | Terminated | 29 May 2019 |
| Z-1397-2019 | AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 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,… | 18 (OUS) | Class II | Terminated | 29 May 2019 |
| Z-1398-2019 | AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 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,… | 1 (OUS) | Class II | Terminated | 29 May 2019 |
| Z-1399-2019 | AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 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,… | 2 (OUS) | Class II | Terminated | 29 May 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 9Median of the firm: 2
- Events of the firm on the register
- 162
Other events of the firm
Official channels
- FDA enforcement report Z-1391-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 82691. https://recallregister.com/fda/ii/82691/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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…
- What quantity of product is in FDA event 82691?
- The event has 9 product records. The first record gives this quantity:
1 (OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.