da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200

FDA device recall Z-1293-2023 · posted 2023-03-28 · Open, Classified

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.

Action taken

On 02/10-13/2023, Intuitive Surgical sent "Urgent Medical Device Correction" letters via email to inform two Groups of Customer (Group 1 and Group 2) that, a population of da Vinci Z and Xi Systems instrument arms (USMs-Universal Surgical Manipulators) have instrument Carriages that may separate from the Insertion Axis Linear Rail during shipping, handling, or repositioning of the arms when the system is powered down. The Instrument Carriage would remain attached to the drive motor which prevents free-fall motion or complete detachment from the USM. However, the Instrument Carriage may feel like it is not tightly connected to the rail. This condition may also lead to increased friction along the insertion axis. Instructions for Customers in Group 1 (reference Appendix A of their Letter): Stop/Cease use of the affected systems until Intuitive Representatives can replace the affected USMs on their systems. Instructions for Customers in Group 2 (reference Appendix B of their Letter): Can continue to use affected systems, but prior to each use, need to perform inspection of all the instrument carriages using the "Instrument Carriage Inspection Instructions" (refer letter for details of inspection). For questions or additional guidance: -US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. -Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@intusurg.com -South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or support.korea@intusurg.com -Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com -Taiwan: 886-2-2-27008181 (9 AM to 6:00 PM CST) or CS.taiwan@intusurg.com -India: 1800 103 6952 (9:00 AM to 6:00 PM IST) or Email address: support.india@intusurg.com

Root cause

Equipment maintenance

Status

Open, Classified

Product code

NAY

Quantity affected

1,225 total USMs

Distribution

U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion,

Date initiated

2023-02-10

Date posted

2023-03-28

Location

Sunnyvale, CA

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