Z-1994-2014Class II

Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical...

Name: Z-1994-2014 Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical...
Creator: Intuitive Surgical, Inc.
Published: 2012-04-27
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2012-04-27 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086 on 2012-04-27. FDA classified it as Class II and gives the reason as "Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1994-2014
Classification: Class II
Status: Terminated
Initiated: 2012-04-27
Posted: 2014-07-04
Terminated: 2014-07-07
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
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
Root cause tag: design
FDA root cause: Device Design
Action: No notification was sent. Issue is being addressed during routine maintenance or through complaint process.
Quantity in commerce: 2606
Distribution: Worldwide Distribution.
Product codes and lots: Material number 371268-02 - al lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1994-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1994-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-04

Product code NAY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)