CLASS II Device recall · Reported 2 Nov 2016 · FDA Enforcement Report
da Vinci¿ Xi" Surgical System recalled by Intuitive Surgical
Intuitive Surgical is recalling da Vinci¿ Xi" Surgical System, distributed in Puerto Rico. The recall was initiated on 5 Oct 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0315-2017
- FDA event ID
- 75473
- Recalling firm
- Intuitive Surgical, Sunnyvale, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Oct 2016
- FDA classified
- 26 Oct 2016
- Reported
- 2 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 5 Oct 2016 | Recall initiated by company | |
| 26 Oct 2016 | Classified by FDA | +21 days |
| 2 Nov 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
Where it was distributed
Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Qatar, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Questions about this recall
Is da Vinci¿ Xi" Surgical System recalled?
Yes. Intuitive Surgical recalled da Vinci¿ Xi" Surgical System on 5 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-0315-2017.
Why was it recalled?
Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances
Which lots are affected?
All systems manufactured with or upgraded to P5 software.
Where was it sold?
Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Qatar, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Intuitive Surgical
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|---|---|---|---|---|---|
| Device | CLASS II | da Vinci SP Instrument Arm Drape, SP recalled by Intuitive Surgical | Intuitive Surgical | Other | Nationwide |
| Device | CLASS II | Da Vinci ASSY, PSS, SP1098 recalled by Intuitive Surgical | Intuitive Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Da Vinci 5 Assy,DV5 Tower,IS5000 recalled by Intuitive Surgical | Intuitive Surgical | Device Malfunction | 49 states |
| Device | CLASS I | Intuitive SureForm 30 Gray Reloads Reference Numbers recalled | Intuitive Surgical | Other | 49 states |
| Device | CLASS II | Da Vinci X and Da Vinci Xi da Vinci X, Xi Surgical System recalled | Intuitive Surgical | Device Malfunction | Nationwide |
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