Recall Z-1906-2020— Intuitive Surgical, Inc.

Name: FDA recall Z-1906-2020
Creator: U.S. Food and Drug Administration
Published: 2018-10-25

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2018-10-25, terminated 2024-04-05. It names one FDA 510(k) clearance: K173906. Product: da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch. Reason: The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-10-25
Terminated: 2024-04-05
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K173906 — da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.·cleared 2018-05-31

K-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 SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch

Reason for recall

The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.

Data sourced from openFDA. This site is unofficial and independent of the FDA.