| Date Initiated by Firm |
May 08, 2015 |
| Date Posted |
November 17, 2015 |
| Recall Status1 |
Terminated 3 on February 28, 2017 |
| Recall Number |
Z-0282-2016 |
| Recall Event ID |
71248 |
| 510(K)Number |
K070106
|
| Product Classification |
Neurological stereotaxic Instrument - Product Code HAW
|
| Product |
BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery. |
| Code Information |
Model/catalogue numbers: 19060 AIR ICT S&T W/O G.C. NEUROLOGICA BODYTOM; 19065 MOBILE iCT AUTOMATIC IMAGE REG. CRANIAL. Potentially affected is the integration of the NeuroLogica BodyTom portable CT scanner for automatic registration with Brainlab Navigation devices (Cranial / ENT version 2.1 and Spine & Trauma 3D versions 2.0 and 2.1) |
Recalling Firm/
Manufacturer |
Brainlab AG
Kapellenstrasse 12
Feldkirchen Germany
|
| For Additional Information Contact |
Julia Mehltretter
49-89991568 Ext. 0
|
Manufacturer Reason
for Recall |
Instances of data sets not being accurately registered to the patient anatomy were observed.
|
FDA Determined
Cause 2 |
Nonconforming Material/Component |
| Action |
A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated April 30, 2015 was sent to all direct accounts (customers). The letters included instructions for customers to:
To reduce the risk of an inappropriate automatic registration, Brainlab, in cooperation with NeuroLogica, has developed an improved integration- and verification-workflow to be followed, and additionally wants to re-iterate important use instructions, as described below and specified in detail in the Appendix of this document.
When using Brainlab's navigation software to perform automatic registration of CT image data sets in combination with NeuroLogica BodyTom, please ensure that the following conditions are always fulfilled:
1) Ensure suitability of OR Ensure that the operating room where the BodyTom is used in combination with the Brainlab navigation has a continuously even floor. The flatness must not exceed 1mm (0.04 in) for 1m (39.4 in).
Please take into account that the flatness may change over time due to wear of the floor coating material and/or negative impacts under the load of equipment used in the room. Ensure that the OR still fulfills the initial specifications before use.
2) Ensure a valid calibration of the BodyTom
Automatic registration with the BodyTom may only be used if a valid calibration and verification of the BodyToms mechanical position is given. Both BodyTom and Brainlab calibration must be performed on the same position and movement path that is used for the navigated clinical procedure. The use of Brainlab navigation system is restricted to the one room and movement path where the calibration has been performed. If multiple calibrated rooms are listed on the BodyTom, please ensure that the correct room is selected on the BodyTom workstation when preparing the scan. As part of the Brainlab Corrective Action (see below) you will be contacted by a Brainlab employee to assist in the selection and marking of a suitable movement path and to perform th |
| Quantity in Commerce |
12 systems total (10 in U.S., 2 in Australia) |
| Distribution |
Distributed in the US and Australia. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = HAW and Original Applicant = BRAINLAB AG
|
