FDA Device recall Z-1048-2015
da Vinci Si Surgical System, IS3000
- FDA Device
- Class II
- terminated
- Published 2015-02-11
On 2015-02-11 the FDA classified a Class II recall of da Vinci Si Surgical System, IS3000 by Intuitive Surgical, citing the Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1048-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-15 |
| Published | 2015-02-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Reason
The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time.
Identifiers
| code_info | PN 410298-05, -06, -07, -08, -09 |
|---|
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-1048-2015%22
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