FDA Device recall Z-0275-2022
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart…
- FDA Device
- Class II
- terminated
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class II recall of The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart… by Intuitive Surgical, citing incorrect expiration date on its package labeling (shipper box and inner carton label).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0275-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-21 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist 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 system and its primary function is to support the instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.
Reason
Incorrect expiration date on its package labeling (shipper box and inner carton label).
Identifiers
| code_info | Part number: 470015-07; Lot number: DM4210309; REF: 470015; UDI # 00886874112199. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0275-2022%22
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