ClearanceBrief
Recall Z-1994-2014 ยท NAY System, Surgical, Computer Controlled Instrument

Intuitive Surgical, Inc.

Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086

DateJul 4, 2014 (initiated Apr 27, 2012)
StatusTerminated
ReasonPatient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
Root causeDevice Design
ActionNo notification was sent. Issue is being addressed during routine maintenance or through complaint process.
Quantity2606
DistributionWorldwide Distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
Intuitive Surgical, Inc., Apr 29, 2005
K081137INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
Intuitive Surgical, Inc., Feb 18, 2009