FDA Device recall Z-3254-2018

da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Pa…

FDA Device
Class II
terminated
Published 2018-10-03

On 2018-10-03 the FDA classified a Class II recall of da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Pa… by Intuitive Surgical, citing certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-3254-2018
Classification	Class II
Status	terminated
Initiated	2018-07-16
Published	2018-10-03
Last updated	2026-09-13 11:54 UTC
Company	Intuitive Surgical
Distribution	US

Product

da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional.

Reason

Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.

Identifiers

code_info	Model Name: Model Number: UDI Number: da Vinci Si Surgical System IS3000 00… Model Name: Model Number: UDI Number: da Vinci Si Surgical System IS3000 00886874110744 System/Console Name/Number: SH2433 SH2433 SH2406 SH2407 RSH0112 RSH0201 SH0948 SH2441 SH2409 SH2430 SH2412 SH2419 SH2409 SH2430 SH2441 SH2449 SH2446 SH2448 SH2402 SH2418 SH2421 SH2418 SH2404 SH2442 SH2421 SH2423 SH2425 SH2423 SH2426 SH2426 SH2442 SH2420 SH2415 SH2444 SH2422 SH2444 SH2435 SH2443 SH2431 SH2437 SH2447 SH2443 SH2445 SH2434 SH2450 RSH0159 RSH0137 RSH0140 RSH0165 RSH0204 RSH0167 RSH0166 RSH0180 RSH0181 RSH0205 RSH0229 RSH0155 RSH0163 RSH0160 RSH0170 SH2413 SH2413 SH2413 SH2408 RSH0210 SH2440 SH2410 SH2424 SH1681 RSH0126 SH0185 RSH0082 RSH0009 RSH0164 RSH0161 RSH0162 RSH0176 SC0042 SH1641 SH2038 SH0215 RSH0043 SH1133 RSH0209 SH0473 SH1786 RSH0120 SH2432 SH0272 SH0232 SC0045 SH0261 SH0925 SH0157 SH2436 SH2436 SH2438 da Vinci X Surgical System IS4

code_info

Model Name: Model Number: UDI Number: da Vinci Si Surgical System IS3000 00…

Model Name: Model Number: UDI Number: da Vinci Si Surgical System IS3000 00886874110744 System/Console Name/Number: SH2433 SH2433 SH2406 SH2407 RSH0112 RSH0201 SH0948 SH2441 SH2409 SH2430 SH2412 SH2419 SH2409 SH2430 SH2441 SH2449 SH2446 SH2448 SH2402 SH2418 SH2421 SH2418 SH2404 SH2442 SH2421 SH2423 SH2425 SH2423 SH2426 SH2426 SH2442 SH2420 SH2415 SH2444 SH2422 SH2444 SH2435 SH2443 SH2431 SH2437 SH2447 SH2443 SH2445 SH2434 SH2450 RSH0159 RSH0137 RSH0140 RSH0165 RSH0204 RSH0167 RSH0166 RSH0180 RSH0181 RSH0205 RSH0229 RSH0155 RSH0163 RSH0160 RSH0170 SH2413 SH2413 SH2413 SH2408 RSH0210 SH2440 SH2410 SH2424 SH1681 RSH0126 SH0185 RSH0082 RSH0009 RSH0164 RSH0161 RSH0162 RSH0176 SC0042 SH1641 SH2038 SH0215 RSH0043 SH1133 RSH0209 SH0473 SH1786 RSH0120 SH2432 SH0272 SH0232 SC0045 SH0261 SH0925 SH0157 SH2436 SH2436 SH2438 da Vinci X Surgical System IS4

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3254-2018%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.