| Class 2 Device Recall daVinci S Surgical System IS2000 | |
Date Initiated by Firm | May 14, 2007 |
Date Posted | September 26, 2007 |
Recall Status1 |
Terminated 3 on December 03, 2007 |
Recall Number | Z-1245-2007 |
Recall Event ID |
38301 |
510(K)Number | K050369 K063220 |
Product Classification |
endoscopic instrument control system - Product Code NAY
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Product | daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Intuitive Surgical, Inc. 950 Kifer Rd Sunnyvale CA 94086-5206
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For Additional Information Contact | 408-523-2100 |
Manufacturer Reason for Recall | Product may malfunction and fail to start up on AC power. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = NAY
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