🔍 RecallPedia

ROSA Brain 3.0 Application-Brain

Class I - Dangerous
🏥 Medical Devices Recalled: January 6, 2020 MEDTECH SAS Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, BR16025, BS16904, BS16905, BS16910, BS16916, BS16917, BS16923, Additional Serial Numbers / UDI: 1) BR17030 / UDI - (01)03760244031754(11)180309(21)BR17030; 2) BR17034, BS17934 / UDI - (01)03760244031754(11)180315(21)BR17034; 3) BR17035, BS17935 / UDI - (01)03760244031754(11)180315(21)BR17035; 4) BR17036 / UDI - (01)03760244031754(11)180417(21)BR17036; 5) BR17037, BS17937 / UDI - (01)03760244031754(11)180313(21)BR17037; 6) BR18024 / UDI - (01)03760244031754(11)180321(21)BR18024; 7) BR18031 / UDI - (01)03760244031754(11)180309(21)BR18031; 8) BR18038 / UDI - BS18938 "(01)03760244031754(11)180430(21)BR18038; 9) BR18039 / UDI - (01)03760244031754(11)180416(21)BR18039; 10) BR18040, BS18940 / UDI - (01)03760244031754(11)180427(21)BR18040; 11) BR18041, BS18941 / UDI - (01)03760244031754(11)180329(21)BR18041; 12) BR18042 / UDI - (01)03760244031754(11)180420(21)BR18042; 13) BR18043, BS18943 / UDI - (01)03760244031754(11)180503(21)BR18043; 14) BR18045, BS18945 / UDI - (01)03760244031754(11)180504(21)BR18045; 15) BR18046, BS18946 / UDI - (01)03760244031754(11)180515(21)BR18046; 16) BR18047 / UDI - (01)03760244031754(11)180413(21)BR18047; 17) BR18048, BS18948 / UDI - (01)03760244031754(11)180608(21)BR18048; 18) BR18049, BS18949 / UDI - (01)03760244031754(11)180625(21)BR18049; 19) BR18050 / UDI - (01)03760244031754(11)180531(21)BR18050; 20) BR18051, BS18951 / UDI - (01)03760244031754(11)180605(21)BR18051; 21) BR18052, BS18952 / UDI - (01)03760244031754(11)180621(21)BR18052; 22) BR18053 / UDI - (01)03760244031754(11)180718(21)BR18053; 23) BR18054 / UDI - (01)03760244031754(11)180710(21)BR18054; 24) BR18055 / UDI - (01)03760244031754(11)180605(21)BR18055; 25) BR18056, BS18956 / UDI - (01)03760244031754(11)180611(21)BR18056; 26) BR18057 / UDI - (01)03760244031754(11)180614(21)BR18057; 27) BR18058 / UDI - (01)03760244031754(11)180717(21)BR18058; 28) BR18059, BS18959 - UDI - (01)03760244031754(11)180627(21)BR18059; 29) BR18060 / UDI - (01)03760244031754(11)180627(21)BR18060; 30) BR18061, BS18961 / UDI - (01)03760244031754(11)180704(21)BR18061; 31) BR18062 / UDI - (01)03760244031754(11)180806(21)BR18062; 32) BR18063 / UDI - (01)03760244031754(11)180807(21)BR18063; 33) BR18064 / UDI - (01)03760244031754(11)180806(21)BR18064; 34) BR18065 / UDI - (01)03760244031754(11)180823(21)BR18065; 35) BR18066, BS18966 / UDI - (01)03760244031754(11)180827(21)BR18066; 36) BR18067 / UDI - (01)03760244031754(11)180903(21)BR18067; 37) BR18068, BS18968 / UDI - (01)03760244031754(11)180813(21)BR18068; 38) BR18069, BS18969 / UDI - (01)03760244031754(11)180820(21)BR18069; 39) BR18070, BS18970 / UDI - (01)03760244031754(11)180829(21)BR18070; 40) BR18071, BS18971 / UDI - (01)03760244031754(11)180904(21)BR18071; 41) BR18072, BS18972 / UDI - (01)03760244031754(11)180831(21)BR18072; 42) BR18073 / UDI - (01)03760244031754(11)180910(21)BR18073; 43) BR18074, BS18974 / UDI - (01)03760244031754(11)181108(21)BR18074; 44) BR18075, BS18975 / UDI - (01)03760244031754(11)180906(21)BR18075; 45) BR18076, BS18976 / UDI - (01)03760244031754(11)180907(21)BR18076; 46) BR18077, BS18977 / UDI - (01)03760244031754(11)180911(21)BR18077; 47) BR18078 / UDI - (01)03760244031754(11)180912(21)BR18078; 48) BR18079 / UDI - (01)03760244031754(11)180912(21)BR18079; 49) BR18080 / UDI - (01)03760244031754(11)180913(21)BR18080; 50) BR18081 / UDI - (01)03760244031754(11)180926(21)BR18081; 51) BR18082 / UDI - (01)03760244031754(11)181009(21)BR18082; 52) BR18083 / UDI - (01)03760244031754(11)181011(21)BR18083; 53) BR18084, BS18984 / UDI - (01)03760244031754(11)181108(21)BR18084; 54) BR18085 / UDI - (01)03760244031754(11)181017(21)BR18085; 55) BR18086, BS18986 / UDI - (01)03760244031754(11)181019(21)BR18086; 56) BR18087, BS18987 / UDI - (01)03760244031754(11)181112(21)BR18087; 57) BR18088, BS18988 / UDI - (01)03760244031754(11)181114(21)BR18088; 58) BR18089 / UDI - (01)03760244031754(11)181109(21)BR18089; 59) BR18090 / UDI - (01)03760244031754(11)181120(21)BR18090; 60) BR18091 / UDI - (01)03760244031754(11)181112(21)BR18091; 61) BR18092 / UDI - (01)03760244031754(11)181128(21)BR18092; 62) BR18093 / UDI - (01)03760244031754(11)181116(21)BR18093; 63) BR18094 / UDI - (01)03760244031754(11)181119(21)BR18094; 64) BR18095, BS18995 / UDI - (01)03760244031754(11)181121(21)BR18095; 65) BR18096, BS18996 / UDI - (01)03760244031754(11)181126(21)BR18096; 66) BR18097 / UDI - (01)03760244031754(11)181129(21)BR18097; 67) BR18098, BS18998 / UDI - (01)03760244031754(11)181123(21)BR18098; 68) BR18099 / UDI - (01)03760244031754(11)181211(21)BR18099; 69) BR18100 / UDI - (01)03760244031754(11)181217(21)BR18100; 70) BR18101 / UDI - (01)03760244031754(11)181221(21)13R18101
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
MEDTECH SAS
Reason for Recall:
Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

ROSA Brain 3.0 Application-Brain

Product Codes/Lot Numbers:

Serial Numbers: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, BR16025, BS16904, BS16905, BS16910, BS16916, BS16917, BS16923, Additional Serial Numbers / UDI: 1) BR17030 / UDI - (01)03760244031754(11)180309(21)BR17030; 2) BR17034, BS17934 / UDI - (01)03760244031754(11)180315(21)BR17034; 3) BR17035, BS17935 / UDI - (01)03760244031754(11)180315(21)BR17035; 4) BR17036 / UDI - (01)03760244031754(11)180417(21)BR17036; 5) BR17037, BS17937 / UDI - (01)03760244031754(11)180313(21)BR17037; 6) BR18024 / UDI - (01)03760244031754(11)180321(21)BR18024; 7) BR18031 / UDI - (01)03760244031754(11)180309(21)BR18031; 8) BR18038 / UDI - BS18938 "(01)03760244031754(11)180430(21)BR18038; 9) BR18039 / UDI - (01)03760244031754(11)180416(21)BR18039; 10) BR18040, BS18940 / UDI - (01)03760244031754(11)180427(21)BR18040; 11) BR18041, BS18941 / UDI - (01)03760244031754(11)180329(21)BR18041; 12) BR18042 / UDI - (01)03760244031754(11)180420(21)BR18042; 13) BR18043, BS18943 / UDI - (01)03760244031754(11)180503(21)BR18043; 14) BR18045, BS18945 / UDI - (01)03760244031754(11)180504(21)BR18045; 15) BR18046, BS18946 / UDI - (01)03760244031754(11)180515(21)BR18046; 16) BR18047 / UDI - (01)03760244031754(11)180413(21)BR18047; 17) BR18048, BS18948 / UDI - (01)03760244031754(11)180608(21)BR18048; 18) BR18049, BS18949 / UDI - (01)03760244031754(11)180625(21)BR18049; 19) BR18050 / UDI - (01)03760244031754(11)180531(21)BR18050; 20) BR18051, BS18951 / UDI - (01)03760244031754(11)180605(21)BR18051; 21) BR18052, BS18952 / UDI - (01)03760244031754(11)180621(21)BR18052; 22) BR18053 / UDI - (01)03760244031754(11)180718(21)BR18053; 23) BR18054 / UDI - (01)03760244031754(11)180710(21)BR18054; 24) BR18055 / UDI - (01)03760244031754(11)180605(21)BR18055; 25) BR18056, BS18956 / UDI - (01)03760244031754(11)180611(21)BR18056; 26) BR18057 / UDI - (01)03760244031754(11)180614(21)BR18057; 27) BR18058 / UDI - (01)03760244031754(11)180717(21)BR18058; 28) BR18059, BS18959 - UDI - (01)03760244031754(11)180627(21)BR18059; 29) BR18060 / UDI - (01)03760244031754(11)180627(21)BR18060; 30) BR18061, BS18961 / UDI - (01)03760244031754(11)180704(21)BR18061; 31) BR18062 / UDI - (01)03760244031754(11)180806(21)BR18062; 32) BR18063 / UDI - (01)03760244031754(11)180807(21)BR18063; 33) BR18064 / UDI - (01)03760244031754(11)180806(21)BR18064; 34) BR18065 / UDI - (01)03760244031754(11)180823(21)BR18065; 35) BR18066, BS18966 / UDI - (01)03760244031754(11)180827(21)BR18066; 36) BR18067 / UDI - (01)03760244031754(11)180903(21)BR18067; 37) BR18068, BS18968 / UDI - (01)03760244031754(11)180813(21)BR18068; 38) BR18069, BS18969 / UDI - (01)03760244031754(11)180820(21)BR18069; 39) BR18070, BS18970 / UDI - (01)03760244031754(11)180829(21)BR18070; 40) BR18071, BS18971 / UDI - (01)03760244031754(11)180904(21)BR18071; 41) BR18072, BS18972 / UDI - (01)03760244031754(11)180831(21)BR18072; 42) BR18073 / UDI - (01)03760244031754(11)180910(21)BR18073; 43) BR18074, BS18974 / UDI - (01)03760244031754(11)181108(21)BR18074; 44) BR18075, BS18975 / UDI - (01)03760244031754(11)180906(21)BR18075; 45) BR18076, BS18976 / UDI - (01)03760244031754(11)180907(21)BR18076; 46) BR18077, BS18977 / UDI - (01)03760244031754(11)180911(21)BR18077; 47) BR18078 / UDI - (01)03760244031754(11)180912(21)BR18078; 48) BR18079 / UDI - (01)03760244031754(11)180912(21)BR18079; 49) BR18080 / UDI - (01)03760244031754(11)180913(21)BR18080; 50) BR18081 / UDI - (01)03760244031754(11)180926(21)BR18081; 51) BR18082 / UDI - (01)03760244031754(11)181009(21)BR18082; 52) BR18083 / UDI - (01)03760244031754(11)181011(21)BR18083; 53) BR18084, BS18984 / UDI - (01)03760244031754(11)181108(21)BR18084; 54) BR18085 / UDI - (01)03760244031754(11)181017(21)BR18085; 55) BR18086, BS18986 / UDI - (01)03760244031754(11)181019(21)BR18086; 56) BR18087, BS18987 / UDI - (01)03760244031754(11)181112(21)BR18087; 57) BR18088, BS18988 / UDI - (01)03760244031754(11)181114(21)BR18088; 58) BR18089 / UDI - (01)03760244031754(11)181109(21)BR18089; 59) BR18090 / UDI - (01)03760244031754(11)181120(21)BR18090; 60) BR18091 / UDI - (01)03760244031754(11)181112(21)BR18091; 61) BR18092 / UDI - (01)03760244031754(11)181128(21)BR18092; 62) BR18093 / UDI - (01)03760244031754(11)181116(21)BR18093; 63) BR18094 / UDI - (01)03760244031754(11)181119(21)BR18094; 64) BR18095, BS18995 / UDI - (01)03760244031754(11)181121(21)BR18095; 65) BR18096, BS18996 / UDI - (01)03760244031754(11)181126(21)BR18096; 66) BR18097 / UDI - (01)03760244031754(11)181129(21)BR18097; 67) BR18098, BS18998 / UDI - (01)03760244031754(11)181123(21)BR18098; 68) BR18099 / UDI - (01)03760244031754(11)181211(21)BR18099; 69) BR18100 / UDI - (01)03760244031754(11)181217(21)BR18100; 70) BR18101 / UDI - (01)03760244031754(11)181221(21)13R18101

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1150-2020

Related Recalls

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.

MEDTECH SAS

Class I - Dangerous

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.

Sep 22, 2021 Surgical Instruments Nationwide View Details →

ROSA One 3.1 Brain Application

MEDTECH SAS

Class I - Dangerous

Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.

Jan 6, 2020 Other Medical Devices Nationwide View Details →

Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.

MEDTECH SAS

Class I - Dangerous

The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.

Sep 10, 2019 Implants & Prosthetics Nationwide View Details →