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.
FDA Recall Z-0638-2018 · Posted None
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Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2017-05-01
Date Terminated2020-07-13
Product Quantity16
Reason for Recall
Robot arm being sent to the wrong position
Firm Action
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.
Root Cause
Software design
Distribution Pattern
Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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