CLASS II Device recall · Reported 14 Oct 2020 · FDA Enforcement Report
Ultrasound Navigation recalled by Brainlab AG
Brainlab AG is recalling Ultrasound Navigation, distributed nationwide in the US. The recall was initiated on 31 Aug 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0056-2021
- FDA event ID
- 86438
- Recalling firm
- Brainlab AG, Munich, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Aug 2020
- FDA classified
- 6 Oct 2020
- Reported
- 14 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 31 Aug 2020 | Recall initiated by company | |
| 6 Oct 2020 | Classified by FDA | +36 days |
| 14 Oct 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide CaliforniaConnecticutIdahoIllinoisMassachusettsMissouriOregonTexas
Questions about this recall
Is Ultrasound Navigation recalled?
Yes. Brainlab AG recalled Ultrasound Navigation on 31 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-0056-2021.
Why was it recalled?
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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