Siemens Recalls SimView NT Radiation Therapy Simulation Systems
Siemens is recalling 65 SimView NT radiation therapy simulation systems worldwide because a rare mechanical failure could prevent the stopping of intended component movements.
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 is classified as FDA Class II, and the hazard involves a mechanical failure in a medical device that could lead to injury, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 65 active units of the SIMVIEW NT and SIMVIEW NT with IDI radiation therapy simulation systems. The recall covers devices distributed in the United States and internationally, including locations in California, Louisiana, Massachusetts, Pennsylvania, New York, Kentucky, and Michigan, as well as numerous countries in Europe, Asia, Africa, and the Americas.
The recall is due to a rare occurrence where an intended movement of the simulation system components could not be stopped using the usual hand control or the collision detection functionality. The devices were manufactured by Mecaserto (now known as Mecasim) in France and distributed by Siemens. Siemens ceased distribution of the Simview system on October 1, 2012.
This is a Class II recall, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible health consequences. Affected facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue.
The recalled product
- Product
- SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 65
Distribution
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