Recall Z-1393-2015— Intuitive Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2015-03-16, terminated 2015-12-03. It names one FDA 510(k) clearance: K050322. Product: da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 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: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-16
- Terminated
- 2015-12-03
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.