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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86046

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 16, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Brainlab AG

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

2 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 2

BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011

Z-2792-2020
Recall number
Z-2792-2020
Initiated
July 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Brainlab AG
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect manufacturer calibration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect manufacturer calibration

Code information

CURVE 1.1 DUAL NAVIGATION STATION, Serial Numbers: 3911619001-19901, S/N of affected NDI Camera: P7-21527 1173019001-19901B, S/N of affected NDI Camera: P7-21173 1444519001-19901B, S/N of affected NDI Camera: P7-21183 1937319001-19901B, S/N of affected NDI Camera: P7-21325 2201419001-19901B, S/N of affected NDI Camera: P7-21324 2456219001-19901B, S/N of affected NDI Camera: P7-21382 3524219001-19901B, S/N of affected NDI Camera: P7-21414 5379420001-19901B, S/N of affected NDI Camera: P7-21830 5609520001-19901B, S/N of affected NDI Camera: P7-21892 6968320001-19901B, S/N of affected NDI Camera: P7-20390 4593720001-19901B, S/N of affected NDI Camera: P7-21655 7850820001-19901B, S/N of affected NDI Camera : P7-22083 6393920001-19901B, S/N of affected NDI Camera: P7-21895 3844314001-19901B, S/N of affected NDI Camera: P7-21449 CURVE DUAL DISPLAY NAVIGATION STATION, Serial Numbers: 0824912001-19900, S/N of affected NDI Camera: P7-21890 3894613001-19900, S/N of affected NDI Camera: P7-21780 4387415001-19900, S/N of affected NDI Camera:P7-07290 CURVE SINGLE DISPLAY NAVIGATION STATION, Serial Number: 5762713001-19905, S/N of affected NDI Camera: P7-10719

Distribution pattern

USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain

device · product 2 of 2

BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655

Z-2793-2020
Recall number
Z-2793-2020
Initiated
July 16, 2020
Classification
Class II
Status
Terminated
Recalling firm
Brainlab AG
Quantity
9 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect manufacturer calibration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect manufacturer calibration

Code information

KICK 2 NAVIGATION STATION, Serial Numbers: 0164217001-18170, S/N of affected NDI Camera: P7-12520 2703119001-18170, S/N of affected NDI Camera:P7-20938 2933119001-18170, S/N of affected NDI Camera:P7-21378 6171619001-18170, S/N of affected NDI Camera:P7-18830 8745417001-18170, S/N of affected NDI Camera:P7-15162 9178819001-18170, S/N of affected NDI Camera:P7-16025 9607118001-18170, S/N of affected NDI Camera:P7-13227 5469918001-18170, S/N of affected NDI Camera: P7-14965 KICK NAVIGATION STATION, Serial Number: 1190017001-18070, S/N of affected NDI Camera: P7-06110

Distribution pattern

USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain