Reported Dec 1, 2021 · Terminated
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- The da Vinci Xi and X surgical systems (IS4000 and IS4200)
- each consist of three main componentsthe 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
- Lot codes and dates
- Part number470015-07
- Lot numberDM4210309
- REF
470015UDI # 00886874112199
- Amount recalled
- 1,740 drapes (87 bobes)
Where it was sold
Why it was recalled
Incorrect expiration date on its package labeling (shipper box and inner carton label).
This product could cause temporary or reversible health problems — stop using it.
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