ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments hold
Summary
The FDA issued a Class I for ROSA One 3.1 Brain application The device is intended for the spatial positio by MEDTECH SAS. 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 .
Details
Source
Device Recall
External ID
Z-0118-2022
Action Date
2021-11-03
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 119 (US); 55 (OUS)
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
US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-22
Company
Montpellier, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 124 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDTECH SAS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDTECH SAS have FDA actions?
This is the only FDA action we have on record for MEDTECH SAS in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0118-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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