—#53387

Product

Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Intuitive Surgical, Sunnyvale, CA 94086.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K050369, K060322
Affected lot / code info: Model Number: IS 2000, Software Revision Numbers: A5.0 P5 and A5.1 P1. System Numbers: all starting with "SG"-- 043, 156, 088, 128, 065, 104, 106, 132, 019, 051, 058, 083, 092, 096, 165, 170, 098, 105, 157, 050, 112, 125, 138, 149, 034, 061, 121, 030, 044, 052, 054, 068, 069, 123, 147, 151, 013, 113, 152, 014, 049, 077, 134, 136, 066, 085, 091, 129, 087, 139, 140, 042, 047, 031, 089, 017, 021, 022, 115, 116, 137, 155, 168, 169, 041, 095, 119, 163, 164, 114, 057, 060, 101, 117, 122, 029, 020, 028, 056, 093, 094, 141, 103, 072, 084, 011, 024, 036, 053, 059, 144, 145, 146, 026, 074, 154, 018, 027, 055, 070, 109, 110, 111, 118, 120, 135, 099, 232, 033, 082, 148, 012, 015, 039, 067, 102, 124, 161, 166, 037, 097, 040, 064, 090, 127, 133, 025, 062, 143, 160, 038, 153, 035, 071, 073, 107, 158, 167, 086, 131, 063, 080, 078, 159, 076, 045, 081, 108, 150, 046, 075, 130, 004, 005, 006, 007, 010, 048, and 126

Why it was recalled

System Lock-Up: Software anomalies could cause product failure during use, or on start-up. System transitions to a safe "soft-lock" state.

Root cause (FDA determination)

Software design

Action the firm took

Intuitive Field Service Engineers installed a software upgrade beginning on 03/30/2007, and left a notification letter that the upgrade had been performed at each site. New software level is A5.1 P2.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA, Belgium, China, France, India, Italy, Japan, Korea, Spain, Sweden, Switzerland, UK and Mexico.

Timeline

Recall initiated: 2007-03-30
Posted by FDA: 2008-02-21
Terminated: 2008-09-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53387. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.