FDA DevicesClass II
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Numbe...
Published: February 18, 2026Recall ID: Z-1355-2026Category: devicesCountry: US
Reason for Recall / Hazard
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
Product Description & Identification
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Additional Source Details
| Field | Value |
|---|---|
| City | Sunnyvale |
| State | CA |
| Event id | 98205 |
| Address 1 | 1266 Kifer Rd |
| Address 2 | N/A |
| Code info | UDI: 00886874119747, Serial: SQ0326, SQ0336, SQ0341, SQ0345, SQ0346, SQ0356, SQ0367, SQ0368, SQ0375, SQ0377, SQ0379, SQ0380, SQ0386, SQ0387, SQ0389, SQ0394, SQ0395, SQ0398, SQ0401, SQ0404, SQ0412, SQ0413, SQ0415, SQ0419, SQ0420, SQ0422, SQ0425, SQ0427, SQ0428, SQ0432, SQ0433, SQ0436, SQ0443, SQ0447, SQ0448, SQ0451, SQ0454, SQ0457, SQ0458, SQ0462, SQ0464, SQ0469, SQ0470, SQ0662, SQ0727, SQ0740, SQ0761 |
| Postal code | 94086-5304 |
| Report date | 20260218 |
| Product type | Devices |
| Product quantity | 47 |
| Reason for recall | Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251230 |
| Initial firm notification | N/A |
| Center classification date | 20260212 |
Overview
- Recalling FirmIntuitive Surgical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of KS, AZ, MA, FL, MI, NC, IL, DC, TX, KY, MS, CA, MN, NV, NY, WI, ID, GA, CT, SC, UT, VA.