Z-1469-2014Class II

Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to...

Name: Z-1469-2014 Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to...
Creator: Brainlab AG
Published: 2013-11-18
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2013-11-18 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number... on 2013-11-18. FDA classified it as Class II and gives the reason as "The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1469-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-18
Posted: 2014-04-17
Terminated: 2017-07-17
Recalling firm: Brainlab, Inc.
Product: Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in combination with a digitally integrated
Root cause tag: software
FDA root cause: Software design
Action: Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter included instructions for the modification of C-arm configurations: 1) If possible, Use analog image transfer between C-arm and Brainlab Navigation System and to consult with the local Brainlab Customer Support Representative for this modification, and 2) If possible, adjust the image size of the C-arm to 8 bit and to follow the instructions provided with the C-arm and if required to consult the C-arm manufacturer. For measures when performing a Fluoro match registration, the following instructions are provided to reduce the probability that the algorithm results in an inaccurate match: 1) perform the preoperative CT scans according to the descriptions in the Brainlab scan protocol, 2) set the threshold so that a smooth bone surface is displayed and the quality of the chosen bone threshold influences the accuracy of the match result (refer to section "Bone Threshold" in the Software User Guide"), 3) use the Radiolucent Spine Reference Clamp instead of the Spine Reference X-Clamp, 4) make sure that no additional objects (e.g. wires, retractors, instruments, etc.) are within the view of the C-arm. Additional reminders in the letter include: 1) always verify registration accuracy by holding the pointer or instrument tip to at least three anatomical landmarks and verifying their position in the software, 2) verify that the registration is at the correct level on the patient and data set, and 3) accuracy must be checked on the treated bone surface. Brainlab will provide a software update with the issue solved to affected customers tentatively by January 2014. Customers with questions can contact the Customer Hotline at 800-597-5911 or via e-mail at [email protected].
Quantity in commerce: 133 units
Distribution: Worldwide Distribution - US Distribution including the states of AZ, CA,GA, IL, IN, LA, MA, MI, NY, NC, OH, PA, TN, TX and WI and the countries of Australia, Austria, Belgium, Brazil, Chile, Czech Republic, France, Germany, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.
Product codes and lots: Catalog Number: 22264; Serial Numbers: 000000000038012001 , 000000000060912001 , 000000000189912001 , 000000000224912001 , 000000000235512001 , 000000000282912001 , 000000000313612001 , 000000000319412001 , 000000000351112001 , 000000000356912001 , 000000000367212001 , 000000000433712001 , 000000000482012001 , 000000000502812001 , 000000000645612001 , 000000000731112001 , 000000000837312001 , 000000000898312001 , 000000000956812001 , 000000000998412001 , 000000001012812001 , 000000001105412001 , 000000001231812001 , 000000001353512001 , 000000001355412001 , 000000001433712001 , 000000001473712001 , 000000001493512001 , 000000001493712001 , 000000001566212001 , 000000001579112001 , 000000001635112001 , 000000001758212001 , 000000001770212001 , 000000001789312001 , 000000001868312001 , 000000001895412001 , 000000001909912001 , 000000002036112001 , 000000002309812001 , 000000002439112001 , 000000002468312001 , 000000002503012001 , 000000002573012001 , 000000002682913001 , 000000003000913001 , 000000003053313001 , 000000003066813001 , 000000003071613001 , 000000003087613001 , 000000003109513001 , 000000003109613001 , 000000003230113001 , 000000003246713001 , 000000003304113001 , 000000003331913001 , 000000003379313001 , 000000003453413001 , 000000003453513001 , 000000003622213001 , 000000003671813001 , 000000003744413001 , 000000003758413001 , 000000003819613001 , 000000003824913001 , 000000003866013001 , 000000003937813001 , 000000004094013001 , 000000004147413001 , 000000004356413001 , 000000004404013001 , 000000004489313001 , 000000004489413001 , 000000004505313001 , 000000004821913001 , 000000004882013001 , 000000004905013001 , 000000005396313001 , 000000005407413001 , 000000005505113001 , 000000005506013001 , 000000005531913001 , 000000005552313001 , 000000005578713001 , 000000005659713001 , 000000005702513001 , 000000005788213001 , 000000005817113001 , 000000005904513001 , 000000005904613001 , 000000005904713001 , 000000005904813001 , 000000005946713001 , 000000006046413001 , 000000006046513001 , 000000006096913001 , 000000006136313001 , 000000006233113001 , 000000006296713001 , 000000006426913001 , 000000006427213001 , 000000006621613001 , 000000006621613002 , 000000006656613001 , 000000006792613001 , 000000006833413001 , 000000006839413001 , 000000006998813001 , 000000007000113001 , 000000007122113001 , 000000007172913001 , 000000007405013001 , 000000007588513001 , 000000007637114001 , 000000007679714001 , 000000007698714001 , 000000007784614001 , 000000007859414001 , 000000007906314001 , 000000008020214001 , 000000008031314001 , 000000008184514001 , 000000008193214001 , 000000008199814001 , 000000008214014001 , 000000008259514001 , 000000008383314001 , 000000009718312001 , 000000009720812001 , 000000009781112001 , 000000009802512001 , 000000009901612001 , 000000009983912001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1469-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1469-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-17

Product code HAW

K070106Class IIVv Fluoro 3DBrainlab AG / cleared 2007-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)