FDA Device recall Z-1293-2023
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 by Intuitive Surgical, citing due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1293-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-10 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Intuitive Surgical |
| Distribution | PR |
Product
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Reason
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
Identifiers
| code_info | da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 Part Number: 380647 UDI-DI Code: 00886…da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 Part Number: 380647 UDI-DI Code: 00886874114216 Serial Numbers: RSK8062 RSK8104 RSK8128 RSK8130 RSK8134 RSK8135 RSK8136 RSK8137 RSK8138 RSK8139 RSK8143 RSK8144 RSK8146 RSK8147 RSK8148 RSK8149 RSK8152 RSK8153 RSK8154 RSK8158 RSK8159 RSK8160 RSK8162 RSK8163 RSK8164 RSK8166 RSK8167 RSK8168 RSK8170 RSK8172 SK0050 SK0055 SK0090 SK0091 SK0101 SK0112 SK0128 SK0137 SK0141 SK0151 SK0153 SK0160 SK0169 SK0211 SK0213 SK0221 SK0280 SK0285 SK0329 SK0382 SK0383 SK0393 SK0395 SK0420 SK0429 SK0433 SK0499 SK0511 SK0518 SK0540 SK0548 SK0563 SK0607 SK0612 SK0618 SK0636 SK0644 SK0661 SK0662 SK0710 SK0739 SK0749 SK0751 SK0765 SK0783 SK0805 SK0811 SK0827 SK0852 SK0866 SK0875 SK0893 SK0912 SK0937 SK0957 SK0968 SK0976 SK0980 SK1008 SK1009 SK1040 SK1063 SK1092 SK1101 SK1102 SK1118 SK1136 SK1143 SK1182 SK1187 SK1211 SK1249 SK1251 SK1261 SK1273 SK1290 SK1322 SK1341 SK1382 SK1385 SK1405 SK1423 SK1428 SK1436 SK1450 SK1470 SK1482 SK1535 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1293-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.