FDA DeviceClass IINotable

FDA Recall: Da Vinci ASSY, PSS, SP1098, Part Number: 380601

Date: 2026-07-01
Brand: Intuitive Surgical, Inc.
Category: Medical Device
FDA Class: Class II

Description

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

Hazard

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

Remedy

454

View original recall →
Share:

Related Recalls

2026-07-22 · FDA_DEVICE
FDA Recall: da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Intuitive Surgical, Inc.
2026-06-10 · FDA_DEVICE
FDA Recall: Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software
Intuitive Surgical, Inc.
2026-05-13 · FDA_DEVICE
FDA Recall: Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog
Intuitive Surgical, Inc.
2026-05-13 · FDA_DEVICE
FDA Recall: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Intuitive Surgical, Inc.