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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83482

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

Open FDA event record

Event summary

Timeline bucket
April 11, 2019
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

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

da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) 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 IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. There are 4 USM per da Vinci Xi surgical system.

Z-1896-2020
Recall number
Z-1896-2020
Initiated
April 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical Inc
Quantity
270 USM units on a combination of 100 unique systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.

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

Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.

Code information

UDI: 00886874114216 Device Listing: D215864 Serial Numbers: SK0736, SK0856, SK1318, SK1943, SK2228, SK2236, SK2239, SK2240, SK2242, SK2244, SK2248, SK2251, SK2255, SK2256, SK2259, SK2260, SK2261, SK2266, SK2269, SK2270, SK2274, SK2275, SK2281, SK2283, SK2285, SK2294, SK2295, SK2297, SK2300, SK2303, SK2304, SK2305, SK2310, SK2311, SK2312, SK2313, SK2314, SK2315, SK2317, SK2318, SK2320, SK2327, SK2329, SK2330, SK2331, SK2333, SK2341, SK2342, SK2343, SK2346, SK2348, SK2349, SK2350, SK2353, SK2355, SK2356, SK2358, SK2359, SK2360, SK2362, SK2363, SK2364, SK2365, SK2367, SK2368, SK2369, SK2370, SK2373, SK2374, SK2375, SK2383, SK2385, SK2389, SK2390, SK2393, SK2397, SK2402, SK2404, SK2405, SK2406, SK2412, SK2418, SK2420, SK2437, SK2449, SK2451, SK2452, SK2453, SK2455

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, District of Columbia, FL, GA, IL, IN, IA, KS. MA, MI, MS, NB, NY, OH, PA, TN, TX, VA, WA and WI and the countries of Australia, Belgium, Brazil, France, Germany, India, Italy, Japan, South Korea, Spain, Sweden, and the United Kingdom.

device · product 2 of 2

da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) 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 IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. There are four USM per da Vinci X surgical system.

Z-1897-2020
Recall number
Z-1897-2020
Initiated
April 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical Inc
Quantity
270 USMs on a combination of 100 unique systems (4 USM per system)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.

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

Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.

Code information

UDI: 00886874114216 Device Listing: D295931 Serial Numbers: SL0085, SL0315, SL0317, SL0324, SL0338, SL0350, SL0351, SL0353, SL0354, SL0357, SL0369

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, District of Columbia, FL, GA, IL, IN, IA, KS. MA, MI, MS, NB, NY, OH, PA, TN, TX, VA, WA and WI and the countries of Australia, Belgium, Brazil, France, Germany, India, Italy, Japan, South Korea, Spain, Sweden, and the United Kingdom.