ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientat...
FDA Device Recall #Z-0118-2022 — Class I — September 22, 2021
Recall Summary
| Recall Number | Z-0118-2022 |
| Classification | Class I — Serious risk |
| Date Initiated | September 22, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDTECH SAS |
| Location | Montpellier, N/A |
| Product Type | Devices |
| Quantity | 119 (US); 55 (OUS) |
Product Description
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 for Recall
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.
Distribution Pattern
US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands.
Lot / Code Information
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 BS20086 BS20092 BS20100 BS20103 BS20107 BS21112 BS21115 BS21121 BS21129 BS21137 BS21138 OUS: BS15902 BS15903 BS16007 BS16919 BS16928 BS16929 BS17008 BS17010 BS17013 BS17021 BS17022 BS17023 BS18024 BS18026 BS18027 BS18028 BS18030 BS18031 BS19032 BS19033 BS19034 BS19035 BS19036 BS19042 BS19051 BS19056 BS19062 BS19064 BS20068 BS20069 BS20070 BS20071 BS20074 BS20075 BS20076 BS20077 BS20078 BS20082 BS20084 BS20085 BS20090 BS20095 BS20098 BS20099 BS20102 BS20105 BS20106 BS21108 BS21109 BS21114 BS21124 BS21128 BS21132 BS21133 BS21134
Other Recalls from MEDTECH SAS
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1150-2020 | Class II | ROSA Brain 3.0 Application-Brain | Jan 6, 2020 |
| Z-1151-2020 | Class II | ROSA One 3.1 Brain Application | Jan 6, 2020 |
| Z-0172-2020 | Class I | Rosa Brain 3.0, Model No. ROSA 3.0. The device ... | Sep 10, 2019 |
| Z-2108-2018 | Class II | ROSA(TM) Robotized Stereotactic Assistant, Vers... | May 8, 2018 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.