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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83665

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 10, 2019
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
MEDTECH SAS

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0172-2020
Recall number
Z-0172-2020
Initiated
September 10, 2019
Classification
Class I
Status
Terminated
Recalling firm
MEDTECH SAS
Quantity
93

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software in the Use Environment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

BR16004 BR16005 BR16006 BR16009 BR16010 BR16011 BR16012 BR16012 BR16014 BR16015 BR16016 BR16017 BR16018 BR16021 BR16023 BR16025 BR17030 BR17034 BR17035 BR17036 BR17037 BR18024 BR18031 BR18038 BR18039 BR18040 BR18041 BR18042 BR18043 BR18045 BR18046 BR18047 BR18048 BR18049 BR18050 BR18051 BR18052 BR18053 BR18054 BR18055 BR18056 BR18057 BR18058 BR18059 BR18060 BR18061 BR18062 BR18063 BR18064 BR18065 BR18066 BR18067 BR18068 BR18069 BR18070 BR18071 BR18072 BR18073 BR18074 BR18075 BR18076 BR18077 BR18078 BR18079 BR18080 BR18081 BR18082 BR18083 BR18084 BR18085 BR18086 BR18087 BR18088 BR18089 BR18090 BR18091 BR18092 BR18093 BR18094 BR18095 BR18096 BR18097 BR18098 BR18099 BR18100 BR18101 BR15002 BR15003 BR16019 BR16028 BR16029 BR16026 BR16032

Distribution pattern

Nationwide domestic distribution. Foreign distribution to Australia, France, Switzerland, Taiwan, and Vietnam.