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BRAINLAB SE FDA Inspection Record

FEI 3002619595 · Inspections, Form 483s, warning letters and import refusals

BRAINLAB SE is an FDA-registered facility (FEI 3002619595) located in Munich Bavaria, DE. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Feb 20, 2025: No Action Indicated (NAI)
Inspections on record
4 (4 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
35, latest Feb 10, 2025
Import refusals
8

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Feb 20, 2025No Action Indicated (NAI)No citations listed
Feb 25, 2016No Action Indicated (NAI)No citations listed
Jun 21, 2013No Action Indicated (NAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
Lack of or inadequate DHR procedures (21 CFR 820.184)
May 27, 2011No Action Indicated (NAI)No citations listed

Recalls

Showing the 10 most recent of 35 recalls. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Feb 10, 2025Class IIZ-1392-2025Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record…
Mar 2, 2023Class IIZ-1292-2023Cirq Arm System 2.0
Risk of mechanical instability due to potential manufacturing error of the device
Feb 14, 2023Class IIZ-1259-2023Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System…
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Feb 25, 2022Class IIZ-0733-2022ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0…
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
May 14, 2021Class IIZ-1846-2021ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2…
Display of potential patient movement might be delayed to the user for high dose treatments.
Mar 1, 2021Class IIZ-1185-2021ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current…
Aug 31, 2020Class IIZ-0056-2021Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT…
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
Aug 20, 2020Class IIZ-2925-2020Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of…
Holding force of the Positioning Arm can be reduced by prolonged non-use.
Jul 16, 2020Class IIZ-2792-2020BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900… and 1 more product
Incorrect manufacturer calibration
Sep 25, 2019Class IIZ-0176-2020Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER…
The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1…

FDA record score

25 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

35 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-1392-2025, this FEI as the recalling firmFeb 10, 20254 x 14
Class I recall Z-1082-2019, this FEI as the recalling firmFeb 27, 201915 x 0.253.8
Class II recall Z-1292-2023, this FEI as the recalling firmMar 2, 20234 x 0.62.4
Class II recall Z-1259-2023, this FEI as the recalling firmFeb 14, 20234 x 0.62.4
Class II recall Z-0733-2022, this FEI as the recalling firmFeb 25, 20224 x 0.62.4
Class II recall Z-1846-2021, this FEI as the recalling firmMay 14, 20214 x 0.251
Class II recall Z-1185-2021, this FEI as the recalling firmMar 1, 20214 x 0.251
Class II recall Z-0056-2021, this FEI as the recalling firmAug 31, 20204 x 0.251
Class II recall Z-2925-2020, this FEI as the recalling firmAug 20, 20204 x 0.251
Class II recall Z-2792-2020, this FEI as the recalling firmJul 16, 20204 x 0.251
Class II recall Z-0176-2020, this FEI as the recalling firmSep 25, 20194 x 0.251
Class II recall Z-1205-2019, this FEI as the recalling firmMar 11, 20194 x 0.251
Class II recall Z-1006-2018, this FEI as the recalling firmFeb 14, 20184 x 0.251
Class II recall Z-0320-2018, this FEI as the recalling firmNov 16, 20174 x 0.251
Class II recall Z-0172-2018, this FEI as the recalling firmNov 3, 20174 x 0.251
Class II recall Z-0959-2017, this FEI as the recalling firmOct 27, 201610 years or older, so it adds no points0
Class II recall Z-1929-2016, this FEI as the recalling firmMay 4, 201610 years or older, so it adds no points0
Class II recall Z-0647-2016, this FEI as the recalling firmNov 5, 201510 years or older, so it adds no points0
Class II recall Z-0218-2016, this FEI as the recalling firmSep 21, 201510 years or older, so it adds no points0
Class II recall Z-2795-2015, this FEI as the recalling firmAug 18, 201510 years or older, so it adds no points0
Class II recall Z-2440-2015, this FEI as the recalling firmAug 5, 201510 years or older, so it adds no points0
Class II recall Z-0282-2016, this FEI as the recalling firmMay 8, 201510 years or older, so it adds no points0
Class II recall Z-1582-2015, this FEI as the recalling firmMar 6, 201510 years or older, so it adds no points0
Class II recall Z-1316-2015, this FEI as the recalling firmFeb 16, 201510 years or older, so it adds no points0
Class II recall Z-1215-2015, this FEI as the recalling firmJan 16, 201510 years or older, so it adds no points0
Class II recall Z-0956-2015, this FEI as the recalling firmNov 19, 201410 years or older, so it adds no points0
Class II recall Z-2134-2014, this FEI as the recalling firmJun 27, 201410 years or older, so it adds no points0
Class II recall Z-2146-2014, this FEI as the recalling firmJun 24, 201410 years or older, so it adds no points0
Class II recall Z-2213-2014, this FEI as the recalling firmMay 21, 201410 years or older, so it adds no points0
Class II recall Z-1707-2014, this FEI as the recalling firmApr 15, 201410 years or older, so it adds no points0
Class II recall Z-1513-2014, this FEI as the recalling firmFeb 24, 201410 years or older, so it adds no points0
Class II recall Z-1469-2014, this FEI as the recalling firmNov 18, 201310 years or older, so it adds no points0
Class II recall Z-0967-2014, this FEI as the recalling firmNov 15, 201310 years or older, so it adds no points0
Class II recall Z-2083-2013, this FEI as the recalling firmJul 16, 201310 years or older, so it adds no points0
Class I recall Z-0598-2016, this FEI as the recalling firmApr 22, 201310 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Brainlab SE
Location
Munich Bavaria (DE)
Source
device

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.