Recall Z-0638-2018 ยท HAW Neurological Stereotaxic Instrument
Zimmer Biomet, Inc.
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.
| Date | May 1, 2017 |
| Status | Terminated |
| Reason | Robot arm being sent to the wrong position |
| Root cause | Software design |
| 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 provi |
| Quantity | 16 |
| Distribution | Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172444 | ROSA BRAIN (v3.0.0.5) Medtech S.A, Mar 28, 2018 |