Recall – Surgical system software change results in issue

Company: Intuitive Surgical, Inc.
Date of Enforcement Report: 12/5/2021
Class II

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

Recall Number: Z-0419-2022

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/MANUFACTURER

Intuitive Surgical, Inc. on 9/22/2021. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

46

DISTRIBUTION

U.S. Nationwide

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