FDA Recall
Terminated
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
Recall: Z-1994-2014
·
Initiated April 27, 2012
Recall
- Recall Number
- Z-1994-2014
- Event Number
- 68593
- Firm
- Intuitive Surgical, Inc.
- FEI Number
- 3001675293
- Product Code
- NAY
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- April 27, 2012
- Posted
- July 4, 2014
- Terminated
- July 7, 2014
- Address
- 1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304
Description
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
Reason
Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
Action
No notification was sent. Issue is being addressed during routine maintenance or through complaint process.
Distribution
Worldwide Distribution.
Quantity
2606