FDA Device recall Z-1484-2022

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

FDA Device
Class II
completed
Published 2022-08-10

On 2022-08-10 the FDA classified a Class II recall of 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 by Intuitive Surgical, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1484-2022
Classification	Class II
Status	completed
Initiated	2022-06-22
Published	2022-08-10
Last updated	2026-09-13 11:56 UTC
Company	Intuitive Surgical
Distribution	US

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

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.

Identifiers

code_info	Model Number: 374848-09 UDI -DI Code: 00886874116982 System Serial Numbers: SK1521 SK0614 SK4114 SL0615 SL0724 SK1178 S… Model Number: 374848-09 UDI -DI Code: 00886874116982 System Serial Numbers: SK1521 SK0614 SK4114 SL0615 SL0724 SK1178 SK4098 SL0719 SL0066 SK4353 SK4821 SK4939 SK4099 SL0673 SL0734 SL0736 SK3010 SL0682 SK3857 SK1277 SK4326 SL0666 SK4169 SK4155 SK4327 SK3033 SK1537 SK4100 SK0917 SK4001 SL0581 SK3340 SK4156 SK3870 SL0744 SK1918 SK1227 SK4129 SK4061 SK4152 SK4301 SK4215 SK4217 SL0625 SK4380 SK2459 SK2460 SK0990 SK4146 SK1942 SK1403 SK0071 SK4219 SK4175 SK3391 SK2484 SK1103 SK3389 SK3405 SK0396 SK4254 SK0345 SK4613 SK0821 SK2767 SK3832 SK0549 SK2411 SK1505 SK1837 SK0765 SK4305 SK4081 SK3421 SK4290 SK4145 SK4118 SK4010 SK3066 SK4008 SK2289 SK0788 SK4351 SK4355 SK2076 SK4072 SK4069 SK2608 SL0753 SK4339 SK4282 SK2886 SK0902 SK3833 SK3874 SK2680 SK1494 SK2679 SK3173 SK2245 SK4256 SK4523 SK2209 SK2320 SK3220 SK0682 SK3765 SK4126 SK0679 SK2271 SK1762 SK1848 SK2420 SK1181 SK4180 SK4879 SK2491 SK3941 SK4111 SK1917 SK3917 SK4184 SK4147 SK3707 SK4880 SK3719 SK1594 SK0594 SK1456 SK2120 SK3881 SK1936

code_info

Model Number: 374848-09 UDI -DI Code: 00886874116982 System Serial Numbers: SK1521 SK0614 SK4114 SL0615 SL0724 SK1178 S…

Model Number: 374848-09 UDI -DI Code: 00886874116982 System Serial Numbers: SK1521 SK0614 SK4114 SL0615 SL0724 SK1178 SK4098 SL0719 SL0066 SK4353 SK4821 SK4939 SK4099 SL0673 SL0734 SL0736 SK3010 SL0682 SK3857 SK1277 SK4326 SL0666 SK4169 SK4155 SK4327 SK3033 SK1537 SK4100 SK0917 SK4001 SL0581 SK3340 SK4156 SK3870 SL0744 SK1918 SK1227 SK4129 SK4061 SK4152 SK4301 SK4215 SK4217 SL0625 SK4380 SK2459 SK2460 SK0990 SK4146 SK1942 SK1403 SK0071 SK4219 SK4175 SK3391 SK2484 SK1103 SK3389 SK3405 SK0396 SK4254 SK0345 SK4613 SK0821 SK2767 SK3832 SK0549 SK2411 SK1505 SK1837 SK0765 SK4305 SK4081 SK3421 SK4290 SK4145 SK4118 SK4010 SK3066 SK4008 SK2289 SK0788 SK4351 SK4355 SK2076 SK4072 SK4069 SK2608 SL0753 SK4339 SK4282 SK2886 SK0902 SK3833 SK3874 SK2680 SK1494 SK2679 SK3173 SK2245 SK4256 SK4523 SK2209 SK2320 SK3220 SK0682 SK3765 SK4126 SK0679 SK2271 SK1762 SK1848 SK2420 SK1181 SK4180 SK4879 SK2491 SK3941 SK4111 SK1917 SK3917 SK4184 SK4147 SK3707 SK4880 SK3719 SK1594 SK0594 SK1456 SK2120 SK3881 SK1936

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1484-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.