The da Vinci Xi and X surgical systems recall: Labeling Error
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…
Why was The da Vinci Xi and X surgical systems recalled?
Incorrect expiration date on its package labeling (shipper box and inner carton label).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part number: 470015-07; Lot number: DM4210309; REF: 470015; UDI # 00886874112199.
- 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…
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 1,740 drapes (87 bobes)
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA, GA, IL, FL, CO, TX, MO, OH, MA, WI, NC, LA, UT and the country of South Korea.
- Recall date
- December 1, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)