Home / Recalls / Brainlab AG / Z-0056-2021

Z-0056-2021 Class II Terminated

Recalled by Brainlab AG — Munich, N/A

FDA device recall Z-0056-2021 was initiated by Brainlab AG on August 31, 2020 and is designated Class II. Reason for recall: Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width. The recall status is terminated (terminated February 17, 2021). Affected quantity: 271 units.

Recall Details

Product Type
Devices
Report Date
October 14, 2020
Initiation Date
August 31, 2020
Termination Date
February 17, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
271 units

Product Description

Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

Reason for Recall

Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of Illinois, Massachusetts, Texas, California, Idaho, Missouri, Oregon, Connecticut and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Curacao, Czech Republic, Egypt, Finland, France, Germany, Switzerland, Netherlands, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kuwait, Malaysia, Myanmar, Norway, Pakistan, Romania, Slovakia, South Africa, Spain, Sweden, Thailand, Turkey and United Kingdom.

Code Information

Model/catalogue numbers: 22582 IGSONIC BK MEDICAL SOFTWARE 22582A ULTRASOUND INTEGRATION SW (BK) 22582B ULTRASOUND INTEGRATION SW 22583 LICENSE UPDATE TO IGSONIC SW FOR BK MED 26506 ULTRASOUND SW BK800 SUBSCRIPTION 26506A ULTRASOUND SW BK SUBSCRIPTION 26508A ULTRASOUND SW BK UPDATE UDI: The GTIN for Ultrasound Navigation 1.0 is: 04056481140137 The GTIN for Cranial/ENT Navigation 3.1 is: 04056481132439

Other recalls by Brainlab AG

  • Z-1392-2025 Class II — Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 (February 10, 2025)
  • Z-1292-2023 Class II — Cirq Arm System 2.0 (March 2, 2023)
  • Z-1259-2023 Class II — Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy S (February 14, 2023)
  • Z-0733-2022 Class II — ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. (February 25, 2022)
  • Z-1846-2021 Class II — ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Instal (May 14, 2021)
  • Z-1185-2021 Class II — ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). (March 1, 2021)
  • Z-2925-2020 Class II — Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000 (August 20, 2020)
  • Z-2792-2020 Class II — BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 199 (July 16, 2020)
  • Z-2793-2020 Class II — BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (July 16, 2020)
  • Z-0176-2020 Class II — Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGE (September 25, 2019)

FDA data resources