da Vinci SP Surgical System Software Energy Delivery Defect
Intuitive Surgical recalls 46 da Vinci SP Surgical systems due to software defect causing potential failure or inadvertent delivery of surgical energy. Issue may require surgeon intervention during procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving potential energy delivery malfunction during surgical procedures. No illnesses or injuries have been reported in the source material, but the theoretical hazard of surgical energy delivery failure or inadvertent activation represents a risk-of-harm product category warranting close attention.
Plain-English summary
Intuitive Surgical, Inc. has recalled 46 da Vinci SP Surgical systems using software version OS4 v4.0.0 (P4_B327). Internal engineering evaluation identified a defect affecting the system's energy delivery mechanism.
The affected systems may experience either an inability to deliver surgical energy or inadvertent (unintended) delivery of energy during use. These malfunctions could require operating surgeons to intervene during the procedure and may cause troubleshooting delays.
The recalled systems have been distributed nationwide to Arizona, California, Connecticut, Florida, Illinois, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, and Wisconsin.
The recalled product
- 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…
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All da Vinci SP Surgical systems with software version OS4 v4.0.0 (P4_B327)
Distribution
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