da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
Reported: April 15, 2015 Initiated: March 16, 2015 #Z-1383-2015
Product Description
da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
Reason for Recall
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 442,475 total all drape models
- Distribution
- Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.. Recalled by Intuitive Surgical, Inc.. Units affected: 442,475 total all drape models.
Why was this product recalled? ▼
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 15, 2015. Severity: Moderate. Recall number: Z-1383-2015.
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