Events

Recall of Brainlab AG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Brainlab AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71996
  • Event Risk Class
    Class 2
  • Event Number
    Z-2795-2015
  • Event Initiated Date
    2015-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139559
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Neurological stereotaxic Instrument - Product Code HAW
  • Reason
    Disposable reflective marker spheres (drms) for brainlab image guided surgery (igs) systems: drms spheres may separate at the mid-point where the two halves of the sphere are sealed together.
  • Action
    The firm, Brainlab AG, sent out a" FIELD SAFETY NOTICE/ PRODUCT NOTIFICATION" dated 7/23/2015 to its customers. The firm sent this letter to mitigate the potential effects of the affected Disposable Reflective Marker Spheres (DRMS) when used with Brainlab Image Guided Surgery (IGS) systems. The firm advised the medical users that they should take the following steps prior to each procedure using Brainlab DRMS spheres for Brainlab IGS systems: -Prior to opening the package containing the spheres, visually inspect the spheres in the blister pack for any signs of separation between the two halves of the sphere. If there is any indication that the spheres may have separated, use a different blister pack for the procedure and repeat this step with the new pack. Discard any and all affected spheres and inform your Brainlab support representative about the occurrence of the issue. If there is no visual sign of sphere separation, proceed to the next step. -Prior to the start of the procedure, screw each DRMS sphere onto the tool and tighten. Upon tightening, inspect again to determine whether any separation between the two halves is evident. If separation is evident, remove and discard the affected sphere. Replace your surgical gloves, then replace the separated sphere with a new sphere, inspecting it as above. If no separation is evident, proceed with the clinical procedure. -Be sure to discard and replace your surgical gloves any time that a sphere with evident separation is found upon affixing the sphere to the tool, and every time after a separated sphere was touched. -Caution: Do not affix the sphere to the tool over the surgical area to minimize the risk of a sphere, or any portion thereof, falling onto the patient or into the surgical wound. Also avoid affixing the sphere over other sterile areas (such as surgical trays) to minimize potential contamination in case of sphere separation. -Reminder: In general, do not use defective or deformed marker

Device

Brainlab AG
  • Model / Serial
    Model numbers: 41773G Disposable Reflective Marker Sphere (90 Pcs.) 41774G Disposable Reflective Marker Sphere (270 Pcs.) 41772G Disposable Reflective Marker Sphere (3 Pcs)   Catalogue numbers: 41773G Disposable Reflective Marker Sphere (90 Pcs.) 41774G Disposable Reflective Marker Sphere (270 Pcs.) (Note: 41772G is not available as single item for sale, but contained in the above 41773G or 41774G)   Lot Numbers:  1014213001, C103461502, C107761402, C100111501, C1034813001, C108341301, C101021502, C103881402, C108721402, C101161401, C104761402, C109051301, C101611502, C105541402, C109251402, C102311401, C106521402, C1098312001, C102481502, C106721301 and C110411401.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: TX, CA, TN, NY, LA, IL, MA, PA, OH, AZ, ID, CT, MI, and KY; and countries of: Algeria, Argentina, Australia, Bahrain, Belarus, Bolivia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Malaysia, Malta, Mexico, Moldova, Morocco, Myanmar, Netherlands, Philippines, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, , Venezuela, and Vietnam.
  • Product Description
    Disposable Reflective Marker Spheres || The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. They are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field. Radiology.
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Manufacturer Address
    Brainlab AG, Kapellenstrasse 12, Feldkirchen Germany
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    USFDA