—#128285

Product

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

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K050369, K081137
Affected lot / code info: Material number 371268-02 - al lots.

Why it was recalled

Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.

Root cause (FDA determination)

Device Design

Action the firm took

No notification was sent. Issue is being addressed during routine maintenance or through complaint process.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2012-04-27
Posted by FDA: 2014-07-04
Terminated: 2014-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128285. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.