E-100 Generator electrosurgical units recalled due to preventative maintenance oversight
Intuitive Surgical is recalling 505 E-100 electrosurgical generators because required preventative maintenance was not performed on units distributed worldwide and in the US.
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 a Class II medical device recall with no reported illnesses or injuries. However, the E-100 is a surgical electrosurgical unit used in critical operating-room procedures. Lack of required preventative maintenance on high-risk surgical equipment presents meaningful potential for patient harm, meeting the criteria for High severity.
Plain-English summary
Intuitive Surgical is recalling 505 E-100 Generator electrosurgical units (PN 374848-09). The E-100 is a bipolar electrosurgical unit designed for use with the da Vinci Xi and X surgical systems and is installed on the Vision Cart.
The recall was issued because required preventative maintenance was not performed on the E-100 generators. Preventative maintenance is essential for ensuring proper functioning and safety of surgical equipment during procedures.
The affected units were distributed worldwide, including throughout the United States and in Belgium, Denmark, Germany, Japan, Italy, Monaco, Norway, Sweden, Switzerland, and the United Kingdom. Affected units can be identified by their system serial numbers listed in the recall notice.
Institutions using affected E-100 generators should verify their serial numbers against the recall list and contact Intuitive Surgical. Healthcare providers should ensure that all required preventative maintenance is current on their electrosurgical equipment.
The recalled product
- Product
- The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon…
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 505
Distribution
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