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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83192

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

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Event summary

Timeline bucket
October 23, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Intuitive Surgical, Inc.

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

The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (cannula) and to manipulate the surgical instruments and camera. The Model Number is SP 1098.

Z-0845-2020
Recall number
Z-0845-2020
Initiated
October 23, 2018
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
5 PSCs (Units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.

Code information

The Affected Systems are : SP0022, SP0023, SP0024, SP0025 and SP0026.

Distribution pattern

Product distributed in the US to the following states: Minnesota, New York, Ohio, and Pennsylvania.