FDA Devices recall · Reported May 13, 2020
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 simu
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.
Intuitive Surgical Inc recalled da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS40… - a moderate-severity action.
da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS40… was recalled by Intuitive Surgical Inc in May 13, 2020. Reason: Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm mov…. Check the official notice for the remedy. Verify recall #Z-1897-2020 with the FDA Devices before acting.
The recall
Intuitive Surgical Inc issued this moderate-severity FDA Devices recall-Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm mov….
- Moderate
- severity level
- Class II
- classification
- May 13, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1897-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1897-2020 |
| Date reported | May 13, 2020 |
| Date initiated | April 11, 2019 |
| Recalling firm | Intuitive Surgical Inc |
| Firm location | Sunnyvale, CA |
| Affected scope | 270 USMs on a combination of 100 unique systems (4 USM per system) |
| Distribution | 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, Bra… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1897-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026