FDA Device recall Z-0118-2022
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to…
- FDA Device
- Class I
- ongoing
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class I recall of ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to… by Medtech Sas, citing the firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has receive….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0118-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-09-22 |
| Published | 2021-11-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtech Sas |
| Distribution | US |
Product
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
Reason
The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.
Identifiers
| code_info | Serial Numbers: US: BS16904 BS16905 BS16906 BS16909 BS16910 BS16911 BS16912 BS16913 BS16914 BS16915 BS169…Serial Numbers: US: BS16904 BS16905 BS16906 BS16909 BS16910 BS16911 BS16912 BS16913 BS16914 BS16915 BS16916 BS16917 BS16918 BS16921 BS16923 BS16925 BS17930 BS17934 BS17935 BS17936 BS17937 BS18900 BS18901 BS18924 BS18931 BS18938 BS18939 BS18940 BS18942 BS18943 BS18945 BS18946 BS18947 BS18948 BS18949 BS18950 BS18951 BS18952 BS18953 BS18954 BS18955 BS18956 BS18957 BS18958 BS18959 BS18960 BS18961 BS18962 BS18963 BS18964 BS18965 BS18966 BS18967 BS18968 BS18969 BS18970 BS18971 BS18972 BS18973 BS18974 BS18975 BS18976 BS18977 BS18979 BS18980 BS18981 BS18982 BS18983 BS18984 BS18985 BS18986 BS18987 BS18988 BS18989 BS18990 BS18991 BS18992 BS18993 BS18994 BS18995 BS18996 BS18997 BS18998 BS18999 BS19037 BS19038 BS19039 BS19040 BS19041 BS19043 BS19047 BS19049 BS19050 BS19052 BS19053 BS19054 BS19057 BS19058 BS19059 BS19060 BS19061 BS19065 BS20066 BS20067 BS20072 BS20073 BS20079 BS20080 BS20 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0118-2022%22
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