Z-1245-2007

daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly)...

Name: Z-1245-2007 daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly)...
Creator: Intuitive Surgical, Inc.
Published: 2007-05-14
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2007-05-14 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system on 2007-05-14. The reason FDA records is "Product may malfunction and fail to start up on AC power". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1245-2007
Status: Terminated
Initiated: 2007-05-14
Posted: 2007-09-26
Terminated: 2007-12-03
Recalling firm: Intuitive Surgical, Inc.
Product: daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Product may malfunction and fail to start up on AC power.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: As of 9/12/2007, the firm has conducted a field inspection of any involved units via service visit. No other notice is planned or indicated by the firm's submission. The firm feels that the risk associated with this issue is minimal, and therefore, any advanced notification is unneccessary. If any system failed one or more of the inspection points, its APB (3510404-04) was replaced with a verified APB (351040-04 or 351040-05).
Quantity in commerce: 38 units
Distribution: Worldwide, including USA, France, China, Japan, Mexico, Spain, Italy, Belgium and Singapore.
Product codes and lots: Model number IS2000, part number 351040-04. System numbers SG002, SG004, SG010 , SG032, SG060, SG061, SG064, SG065, SG066, SG067, SG068, SG069, SG070, SG071, SG072, SG073, SG074, SG075, SG076, SG077, SG078, SG079, SG080, SG081, SG082, SG083, SG084, SG086, SG090, SG116, SG117, SG118, SG120, SG121, SG126, SG174, SG175, SG184

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)