Class 2 Device Recall Patient Side Cart Battery Box

• Date Initiated by Firm: April 27, 2012
• Date Posted: July 04, 2014
• Recall Status: Terminated on July 07, 2014
• Recall Number: Z-1994-2014
• Recall Event ID: 68593
• 510(K)Number: K050369 K081137
• Product Classification: System,surgical,computer controlled instrument - Product Code NAY
• Product: Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
• Code Information: Material number 371268-02 - al lots.
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 100; Sunnyvale CA 94086-5304
• For Additional Information Contact: Mark Johnson; 408-523-2100
• Manufacturer Reason for Recall: Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
• FDA Determined Cause: Device Design
• Action: No notification was sent. Issue is being addressed during routine maintenance or through complaint process.
• Quantity in Commerce: 2606
• Distribution: Worldwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NAY