ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Reported: August 8, 2012 Initiated: July 13, 2012 #Z-2106-2012
Product Description
ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Reason for Recall
Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 92390 total instrument Drapes
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.. Recalled by Intuitive Surgical, Inc.. Units affected: 92390 total instrument Drapes.
Why was this product recalled? ▼
Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 8, 2012. Severity: Moderate. Recall number: Z-2106-2012.
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