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Intuitive Surgical, Inc. Recall 93301

Description: Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

Intuitive Surgical, Inc. Recall 93301 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0406-2024
Event ID93301
Event DescriptionDa Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Product TypeDevices
DistributionUS: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea
Quantity317 units
Recall ReasonThere is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
Device Classification20231206
Device Code InfoUDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109
Center Classification Date20231128
Recall Initiation Date20231006
Recalling FirmIntuitive Surgical, Inc.
Initial Notification E-Mail
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