FDA Device recall Z-1109-2013
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000 by Intuitive Surgical, citing revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1109-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-15 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
Reason
Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
Identifiers
| code_info | Model number 550516-05 |
|---|
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-1109-2013%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.