Siemens VersaCell X3 Recall for Insecure Keyboard and Monitor Mounting
Siemens Medical Solutions Diagnostics is recalling 19 VersaCell X3 robotic laboratory systems because the keyboard and monitor may not be properly secured to the monitor arm.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard involves a mechanical mounting issue rather than a direct safety threat like fire or injury.
Plain-English summary
Siemens Medical Solutions Diagnostics is recalling 19 units of the VersaCell X3 Solution and VersaCell X3 Expansion Pack. This robotic laboratory sample-management system connects up to three instruments and provides a user interface to route samples and consolidate results.
The recall was initiated because the keyboard and monitor may not be properly secured to the monitor arm. The affected units were distributed worldwide, including in the United States (specifically Iowa and New York) and internationally to Canada, Chile, France, India, Italy, Malaysia, Peru, Korea, and the United Kingdom.
The specific Siemens Material Numbers for the affected instruments are 10793839 and for the Expansion Pack are 10913528. Users should contact Siemens Medical Solutions Diagnostics for further instructions regarding the repair or replacement of the affected components.
The recalled product
- Product
- VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.
- Manufacturer
- Siemens Medical Solutions Diagnostics
- Hazard
- Affected units
- 19
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 (2)
- Siemens Material Numbers: Instrument 10793839
- Expansion Pack 10913528
Distribution
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