—#53366

Product

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

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K050369, K063220
Affected lot / code info: 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

Why it was recalled

Product may malfunction and fail to start up on AC power.

Root cause (FDA determination)

Process control

Action the firm took

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).

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 950 Kifer Rd, Sunnyvale, California 94086-5206

Distribution

Distribution pattern: Worldwide, including USA, France, China, Japan, Mexico, Spain, Italy, Belgium and Singapore.

Timeline

Recall initiated: 2007-05-14
Posted by FDA: 2007-09-26
Terminated: 2007-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53366. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.