Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale
FDA device recall Z-1994-2014 · posted 2014-07-04 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
- Action taken
- No notification was sent. Issue is being addressed during routine maintenance or through complaint process.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 2606
- Distribution
- Worldwide Distribution.
- Date initiated
- 2012-04-27
- Date posted
- 2014-07-04
- Date terminated
- 2014-07-07
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 (K081137) | Intuitive Surgical, Inc. | 2009-02-18 |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 (K050369) | Intuitive Surgical, Inc. | 2005-04-29 |