Intuitive Surgical Recalls da Vinci Patient Side Manipulator Assemblies
Intuitive Surgical is recalling 1,386 da Vinci Patient Side Manipulator assemblies due to friction that can cause instrument motion to stall and catch up.
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: The recall involves a high-risk medical device where a mechanical defect (friction/stalling) poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Intuitive Surgical, Inc. is recalling 1,386 units of the Assembly, Patient Side Manipulator used in da Vinci S, SI, and Si-e Surgical Systems. The recall covers systems distributed in the United States and internationally to countries including Australia, Canada, China, France, Germany, Japan, and the United Kingdom.
The recall was initiated due to reports of friction within certain instrument arms. This friction can interrupt smooth instrument motion, which surgeons may feel as resistance in the movement of the master controls. In these situations, the instrument can stall momentarily and then suddenly catch up to the master position if the surgeon pushes through the resistance.
The affected products are identified by part numbers 380900-02 and 380900-03. Specific System ID numbers for affected units are listed in the official recall documentation. Healthcare facilities and users should contact Intuitive Surgical for further instructions on managing the affected equipment.
The recalled product
- Product
- Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System…
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 1,386
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 (16)
- Austria: SG579
- Belgium: SG430 SH0034 SH1405 SH1406 SH1638
- Bulgaria: SH1692
- Brazil: SH1768 SG664 SH1866
- Canada: SG242 SG345 SH0260 SH0370 SH1095
- China: SG815 SG831 SH0965 SH1062 SH1582
- Columbia: SH1161
- Denmark: SH0975 SH1168 SH1455 SH1716 SH1756
- Luxembourg: SH1920
- Mexico: SH1931 SH1316
- Monaco: SH0208
- Netherlands: SH0827 SH0923 SH1579 SH1863
- Norway: SH0205 SH1159 SH1297 SH1361
- Romania: SH0161
- Spain: SG2045 SG210 SG796 SG840 SH1443
- Sweden: SH1607 SH1608 SH1757 SH1854 SH1874 SH1938
Distribution
Distributed nationwide across the United States.
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