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Recall Observatory FDA recall evidence

Device product

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

Z-1994-2014

April 27, 2012

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 68593
Status
Terminated
Classification
Class II
Quantity
2606
Official record key
device-enforcement:Z-1994-2014

Official wording

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

Code information: Material number 371268-02 - al lots.

Distribution pattern: Worldwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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