Recall Z-1994-2014— Intuitive Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2012-04-27, terminated 2014-07-07. It names 2 FDA 510(k) clearances: K081137, K050369. Product: 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..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-04-27
- Terminated
- 2014-07-07
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K081137 — INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
- K050369 — INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
Reason for recall
Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.