Intuitive Surgical, Inc. Recall 93301
Description: Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Intuitive Surgical, Inc. Recall 93301 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0406-2024 |
| Event ID | 93301 |
| Event Description | Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm |
| Product Type | Devices |
| Distribution | US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea |
| Quantity | 317 units |
| Recall Reason | There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement. |
| Device Classification | 20231206 |
| Device Code Info | UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109 |
| Center Classification Date | 20231128 |
| Recall Initiation Date | 20231006 |
| Recalling Firm | Intuitive Surgical, Inc. |
| Initial Notification | |
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