Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported January 27, 2016
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure t…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Brainlab Ag recalled Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiol… - a critical-severity action.
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiol… was recalled by Brainlab Ag in January 27, 2016. Reason: Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccura…. Check the official notice for the remedy. Verify recall #Z-0598-2016 with the FDA Devices before acting.
The recall
Brainlab Ag issued this critical-severity FDA Devices recall-Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccura….
- Critical
- severity level
- 3K units
- affected scope
- Class I
- classification
- January 27, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0598-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0598-2016) was formally reported on January 27, 2016, with the manufacturer initiating the action on April 22, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Brainlab Ag is listed as the recalling firm, operating out of Munich, N/A. Federal records list the affected scope as 2528 units / 2119 consignees.
The documented reason for this recall is: Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of i… Distribution data in the federal record shows the product reached: Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmar…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2528 units / 2119 consignees
Related Recalls
6
3 from same agency
Product description
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
Reason for recall
Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0598-2016 |
| Date reported | January 27, 2016 |
| Date initiated | April 22, 2013 |
| Recalling firm | Brainlab Ag |
| Firm location | Munich, N/A |
| Affected scope | 2528 units / 2119 consignees |
| Distribution | Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republi… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0598-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.. Recalled by Brainlab Ag. Units affected: 2528 units / 2119 consignees.
Why was this product recalled? ▼
Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 27, 2016. Severity: Critical. Recall number: Z-0598-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Latvia, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0598-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 27, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.