FDA Device recall Z-1718-2014
Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000
- FDA Device
- Class II
- terminated
- Published 2014-06-11
On 2014-06-11 the FDA classified a Class II recall of Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000 by Intuitive Surgical, citing torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1718-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-09 |
| Published | 2014-06-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | FL, TX |
Product
Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.
Reason
Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.
Identifiers
| code_info | lot 380652-20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1718-2014%22
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