FDA Device recall Z-0419-2022
da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP10…
- FDA Device
- Class II
- ongoing
- Published 2022-01-05
On 2022-01-05 the FDA classified a Class II recall of da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP10… by Intuitive Surgical, citing issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadve….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0419-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-22 |
| Published | 2022-01-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A
Reason
Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.
Identifiers
| code_info | All da Vinci SP Surgical systems with software version OS4 v4.0.0 (P4_B327) |
|---|
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-0419-2022%22
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