Intuitive Surgical Recalls Da Vinci 5 Surgical Consoles Due to Software Error
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Intuitive Surgical, Inc. is recalling 12 Da Vinci 5 surgical consoles across six states due to a software error that may cause external monitors to lose user interface content.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevice.
What Happened
Intuitive Surgical, Inc. has initiated a voluntary recall of certain Da Vinci 5 surgical consoles following the discovery of a software error. The issue, associated with software version P1.2.1, can result in the loss of user interface content on external monitors or tower monitors during surgical procedures.
Which Products Are Affected
The recall involves 12 units of the following product:
- Product Name: Da Vinci 5 ASSY, DV5 CONSOLE, IS5000
- Model/Catalog Number: 380730
- Software Version: P1.2.1
- GTIN: 0886874119747
- UDI-DI: 00886874119747
- Recall Number: Z-1428-2026
These units were distributed to medical facilities in the following states: Louisiana, Massachusetts, New York, Pennsylvania, Texas, and Virginia.
What You Should Do
Intuitive Surgical, Inc. notified affected customers via a formal letter initiated on November 17, 2025. Healthcare providers and facilities using the Da Vinci 5 system should verify if their equipment is running software version P1.2.1. Affected users should follow the specific guidance provided in the firm's notification letter regarding necessary software corrections or system updates.
Why This Matters
The Da Vinci 5 system is utilized for minimally invasive surgeries. A loss of user interface content on external or tower monitors can disrupt the surgical environment and impact the visibility of critical system information for the surgical team. The FDA has classified this as a Class II recall.
Source
This information is based on an official report from the FDA.
Original source: FDA Official Notice ↗
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