Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Data Mismatch
Siemens is recalling RAPIDPoint 405 Blood Gas Analyzers because patient names may be printed with results from a different patient.
What this means for you
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling the RAPIDPoint 405 Blood Gas Analyzer nBili. The recall involves 2,910 units distributed nationwide and in numerous foreign countries.
The recall is due to a potential software issue where the first and/or last name of one patient may be printed with the Patient ID and result data from a different patient. This error can occur even when those specific fields have been turned off for the system.
Healthcare facilities should contact Siemens Healthcare Diagnostics Inc for further instructions on how to address the issue.
The recalled product
- Product
- Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 2,910
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 (1)
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Siemens Healthcare Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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