Events

Recall of Device Recall Airo

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

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
    69993
  • Event Risk Class
    Class 2
  • Event Number
    Z-1016-2015
  • Event Initiated Date
    2014-12-08
  • Event Date Posted
    2015-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132084
  • 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
    System, x-ray, tomography, computed - Product Code JAK
  • Reason
    There is a risk that during the transfer of an image and navigation data to the brainlab curve image guided surgery navigation system after a ct scan, an error may occur, causing either no navigation data or incorrect navigation data being transferred to the curve.
  • Action
    Mobius sent an Urgent Field Safety Notice dated December 8, 2014, to all affected customers. The letter explains the recall and provides advise on action to be taken by the user. The letter also informs consignees that Mobius Imaging is working on a software fix for the software bug/communication error. The final fix is anticipated in early 2015. Advise on action to be taken by the user: The user should be prepared for the potential necessity to perform a manual navigation registration in order to use navigation. In general, do not use navigation data transmitted by the AIRO Mobile CT Scanner of any scan the Brainlab AIR App displayed the "Received Wrong Dataset" error for. To use such scans with the Curve, a manual navigation registration is required. To avoid the possibility of incorrect data from being transferred to the Curve, Mobius Imaging is recommending that customers only select "NO" when they come to the "Continue with same patient" screen after each scan. They can select the same patient under the "Existing Patients" tab and restart the workflow. Additionally, always adequately verify the accuracy of the navigation registration data as required by the Brainlab Curve" Navigation system software and the AERO Operator's Manual. If you require further clarification, please feel free to contact your local Brain lab Customer Support Representative. Customer Hotline: +49 89 99 15 68 44 or +1800 597 5911 (for US customers) or by E-mail: support@brainlab.com (for US customers: us.support@brainlab.com) Fax Brainlab AG: + 49 89 99 15 68 33 Address: Brainlab AG (headquarters), Kapellenstrasse 12, 85622 Feldkirchen, Germany. For questions regarding this recall call 978-615-5025.

Device

Device Recall Airo
  • Model / Serial
    Serial #s: 2251 (#1)*, 2324 (#2), 2328(#3), 2344 (#4), 2346 (#5), AIRO-0106, AIRO-0107*, AIRO-0108, AIRO-0110, AIRO-0111, AIRO-0112, AIRO-0113, AIRO-0114, AIRO-0115, AIRO-0116, AIRO-0117, AIRO-0118, AIRO-0119, AIRO-0120, AIRO-0122, and AIRO-0123. *Demo system
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.
  • Product Description
    Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
  • Manufacturer
    Mobius Imaging, LLC

Manufacturer

Mobius Imaging, LLC
  • Manufacturer Address
    Mobius Imaging, LLC, 323 W Main St, Ayer MA 01432-1239
  • Manufacturer Parent Company (2017)
    Mobius Imaging LLC
  • Source
    USFDA