Z-0419-2022Class II

da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/...

Name: Z-0419-2022 da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/...
Creator: Intuitive Surgical, Inc.
Published: 2021-09-22
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2021-09-22 / Open, Classified / root cause: software

FDA source

Intuitive Surgical, Inc. began a recall of 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 /... on 2021-09-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0419-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-22
Posted: 2021-12-27
Recalling firm: Intuitive Surgical, Inc.
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
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: On 09/22/2021, the firm notified affected customers via mail of "Urgent Medical Device Correction - ISIFA2021-04-C." The letter indicated, "As part of the field action process, please complete the actions below: 1. Ensure that all personnel who use the da Vinci SP System read and understand the contents of this letter. 2. Inform the personnel when the software update has been completed by the Intuitive representative. 3. Complete the attached Acknowledgement Form and return it via fax or email to Intuitive as instructed on the form. 4. Retain a copy of this letter and the acknowledgement form for your files. 5. Contact Technical Support at the number listed below for assistance if you have experienced this issue: US Technical Support: 800-876-1310, Option 1 (24/7) An Intuitive representative will schedule a site visit to install the next available software update. If you require further information or support concerning this Medical Device Notification, please contact your Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: -US Customer Service (800) 876-1310, Option 3 (7 AM to 5 PM EST) or [email protected]."
Quantity in commerce: 46
Distribution: US Nationwide distribution in the states of Arizona, California, Connecticut, Florida, Illinois, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, and Wisconsin.
Product codes and lots: All da Vinci SP Surgical systems with software version OS4 v4.0.0 (P4_B327)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0419-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0419-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-27

Product code NAY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)