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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-1994-2014
Recalling firm
Intuitive Surgical, Inc.
Product
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
Status
Terminated
Initiated
2012-04-27
Posted
2014-07-04
Terminated
2014-07-07
Reason
Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
Root cause
Device Design
Action
No notification was sent. Issue is being addressed during routine maintenance or through complaint process.
Quantity
2606
Distribution
Worldwide Distribution.
Lot, serial or model codes
Material number 371268-02 - al lots.
510(k) numbers
["K050369","K081137"]
PMA numbers
not on file
Product code
NAY
Firm FEI
3001675293
Firm city
Sunnyvale
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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