The da Vinci Xi and X surgical systems (IS4000 recalled

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect expiration date on its package labeling (shipper box and inner carton label).

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide AlabamaCaliforniaColoradoFloridaGeorgiaIllinoisLouisianaMassachusettsMissouriNorth CarolinaOhioTexasUtahWisconsin