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U.S. Department of Health and Human Services

Class 2 Device Recall ROSA One 3.1 Brain Application

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  Class 2 Device Recall ROSA One 3.1 Brain Application see related information
Date Initiated by Firm January 06, 2020
Create Date February 11, 2020
Recall Status1 Terminated 3 on November 05, 2020
Recall Number Z-1151-2020
Recall Event ID 84642
510(K)Number K182417  K172444  K151359  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product ROSA One 3.1 Brain Application
Code Information Serial Number / UDI Number:  1) BS19037 / UDI - (01)03760244030948(11)190423(21)BS19037;  2) BS19038 / UDI - (01)03760244030948(11)190415(21)BS19038;  3) BS19039 / UDI - (01)03760244030948(11)190430(21)BS19039; 4) BS19040 / UDI - (01)03760244030948(11)190513(21)BS19040; 5) BS19041 / UDI - (01)03760244030948(11)190523(21)BS19041; 6) BS19043 / UDI - (01)03760244030948(11)190513(21)BS19043;  7) BS19049 / UDI - (01)03760244032492(11)190730(21)BS19049;  8) BS19050 / UDI - (01)03760244032492(11)190726(21)BS19050; 9) BS19052 / UDI - (01)03760244032492(11)190731(21)BS19052;  10) BS19054 / UDI - (01)03760244032492(11)190912(21)BS19054;  11) BS19057 / UDI - (01)03760244032492(11)191003(21)BS19057;  12) BS19058 / UDI - (01)03760244032492(11)191011(21)BS19058. 
Recalling Firm/
Manufacturer		 MEDTECH SAS
900 Rue Du Mas De Verchant
Montpellier France
For Additional Information Contact
574-371-3071
Manufacturer Reason
for Recall		 Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
FDA Determined
Cause 2		 Software design
Action On January 6, 2020, Zimmer Biomet issued URGENT MEDICAL DEVICE CORRECTION notices to customers via FedEx. Actions Required By Users: Your device can continue to be used, as long as the recommendations below are followed: While the current Instructions For Use do not require the images to be reviewed with ROSA Brain software prior to surgery, they adequately describe the standard workflow and indicate that the image acquisition of the patients head (MRI / CT or 2D X-Ray images) is performed prior to surgery, and is then loaded into the device and used by the surgeon in the preoperative phase to carry out the surgical planning. Due to this potential image management issue, Zimmer Biomet recommends that images be reviewed using the ROSA Brain software prior to surgery. If an issue is detected with the reconstruction and display of the images using the ROSA software, and if the artifacts are located in the Region Of Interest and prevent the surgical planning, then the surgery might have to be cancelled or converted to traditional surgery. However, if the artifacts are not located inside the Region Of Interest and if the surgery planning is successful, the affected device can continue to be used. Transmission of the Medical Device Correction: Please advise the appropriate personnel working in your department with the ROSA system of the content of the letter. Risk Manager Responsibilities: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Complete the Certificate of Acknowledgement. a. Return a digital copy to CorporateQuality.PostMarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 3. If you have further questions or concerns after reviewing the notice, please call Perry Twyford at 281-389-3236 between 9:00 am and 6:00pm EST, Monday through Friday. Alternatively, your questions may be e
Quantity in Commerce 39 units
Distribution US Nationwide
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 = MEDTECH S.A.
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