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Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An… recallZ-1469-2014 · Brainlab AG · initiated Nov 18, 2013

Class II Terminated All recalls posted in April 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Brainlab AG or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Software design

What the company is doing

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].

Recall details

Recall number
Z-1469-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 18, 2013
Posted by the FDA
Apr 17, 2014
Recalling firm
Brainlab AG
Quantity
133 units
Product code
HAW
FDA submissions
K070106
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 description

Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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

Other devices under the same FDA submission

1 device cleared under K070106 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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