da Vinci SP Surgical systems with the following Model Name/ Model Number / ...
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
Components:
Units Affected: 46
Recall Date: Sep 22, 2021
Mfg:
Intuitive Surgical, Inc.
Mfg Country:
United States
Recall ID: 89109
Product ID: 190523
Enforcement Date: Jan 5, 2022
Last Published: Dec 27, 2021
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Emert Number: Z-0419-2022
Emert Status: Notified