ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Recall
- Recall Number
- Z-0638-2018
- Event Number
- 78944
- Firm
- Zimmer Biomet, Inc.
- FEI Number
- 1825034
- Product Code
- HAW
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 1, 2017
- Terminated
- July 13, 2020
- Address
- 56 E Bell Dr, Warsaw, IN, 46582-6989
Description
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Robot arm being sent to the wrong position
Urgent Medical Device Recall (Correction) notices were sent to customers. The letter provided to hospital risk managers and surgeons identified the issue and their responsibilities. These responsibilities included: - Stop using the micromovement function in isocentric mode during Brain Surgery with ROSA Brain 3.0 device. -Reviewing the notification to ensure comprehension of the steps required to be taken prior to the permanent correction that will be implemented on site by a service engineer. - Completing and returning Attachment 1 (Certificate of Acknowledgement) to the e-mail address provided. The firm has prepared a software correction that will be deployed and implemented on site by a MEDTECH representative.
Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
16