Recall Z-0419-2022— Intuitive Surgical, Inc.

Name: FDA recall Z-0419-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-22

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2021-09-22. It names 6 FDA 510(k) clearances: K211316, K211595, K202968 and 3 more. Product: da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A. Reason: Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-09-22
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

6 on FDA's record

K211316 — da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.·cleared 2021-07-23
K211595 — da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.·cleared 2021-06-23
K202968 — Da Vinci SP Surgical SystemIntuitive Surgical, Inc.·cleared 2020-12-22
K192717 — da Vinci SP Surgical SystemIntuitive Surgical, Inc.·cleared 2020-09-28
K182371 — da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.·cleared 2019-03-14
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 Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A

Reason for recall

Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.

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