# FDA recall Z-0419-2022

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2021-09-22.

## Product

da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI:  ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A

## Reason for recall

Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.

## Distribution

US Nationwide distribution in the states of Arizona, California, Connecticut, Florida, Illinois, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, and Wisconsin.

## Key facts

- **Recall number:** Z-0419-2022
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-22
- **Report date:** 2022-01-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0419-2022

## Citation

> AI Analytics. FDA recall Z-0419-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0419-2022. Source: US FDA. Licensed CC0.

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