Siemens RAPIDComm Data Management System Recalled for Incorrect Test Names
Siemens Healthcare Diagnostics Inc is recalling six RAPIDComm Data Management Systems because the 5.0 screen layout displays incorrect test names.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The agency classification is Class III, which is typically a score of 1 or 2. The hazard involves incorrect data display (test names) without reported injuries or deaths, fitting the criteria for a moderate risk of potential misinterpretation rather than immediate physical harm.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling six units of the RAPIDComm Data Management System. This system manages the process of sending and receiving data from Siemens point-of-care (POC) devices and hospital systems located in the hospital network.
The recall is being issued because the RAPIDComm 5.0 Screen Layout will display incorrect test names. The affected systems were distributed worldwide, including in the United States (specifically Oregon and Pennsylvania), Denmark, and the United Kingdom.
The specific serial numbers for the affected units are 4387, 3734, 4177, 4149, 3074, and 4194. Users should contact Siemens Healthcare Diagnostics Inc for further instructions regarding this recall.
The recalled product
- Product
- Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 6
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 (6)
- Serial Numbers: 4387
- 3734
- 4177
- 4149
- 3074
- 4194
Distribution
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