The E-100 Generator — Class II medical device recall Z-1484-2022

Completed recall by Intuitive Surgical, Inc., reported 2022-08-10, distributed nationwide. Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical

Recall number	`Z-1484-2022`
Product type	Medical device
Classification	Class II
Status	Completed
Voluntary or mandated	Voluntary
Recalling firm	Intuitive Surgical, Inc., Sunnyvale, CA, United States
Recall initiated	2022-06-22
Classified	2022-08-01
Reported by FDA	2022-08-10
Distributed	Nationwide (US)
Countries outside the US	BE, CH, DE, DK, GB, IT, JP, NO, SE
Quantity	505 generators
UPC / GTIN / UDI-DI	`00886874116982`
Serial numbers	`RSK8008`, `RSK8009`, `RSK8010`, `RSK8011`, `RSK8013`, `RSK8015`, `RSK8016`, `RSK8017`, `RSK8018`, `RSK8019`, `RSK8020`, `RSK8022`, `RSK8024`, `RSK8025`, `RSK8026`, `RSK8030`, `RSK8031`, `RSK8034`, `RSK8035`, `RSK8036`, `RSK8038`, `RSK8039`, `RSK8070`, `RSK8085`, `SK0071` and 475 more
Model numbers	`374848-09`

Product

The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon Console.

Reason for recall

Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1484-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.