Z-1151-2020Class II

ROSA One 3.1 Brain Application

Name: Z-1151-2020 ROSA One 3.1 Brain Application
Creator: Medtech Sas
Published: 2020-01-06
License: https://open.fda.gov/license/

MedTech SAS / initiated 2020-01-06 / Terminated / root cause: software

FDA source

MEDTECH SAS began a recall of ROSA One 3.1 Brain Application on 2020-01-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1151-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-06
Posted: 2020-02-11
Terminated: 2020-11-05
Recalling firm: MedTech SAS
Product: ROSA One 3.1 Brain Application
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: software
FDA root cause: 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 [email protected]. 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1151-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1150-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-11
Z-1151-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-11

Product code HAW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)