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Terminated

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

FDA Recall Z-1245-2007 · Posted 2007-09-26

Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2007-05-14
Date Terminated2007-12-03
Product Quantity38 units

Reason for Recall

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

Firm 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).

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063220DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000Intuitive Surgical, Inc. · 2006-12-01K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000Intuitive Surgical, Inc. · 2005-04-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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