Siemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Patient Data Mismatch
Siemens is recalling 492 RAPIDPoint 400 Blood Gas Analyzers because patient names may be printed with data 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 is classified as FDA Class II and involves a risk of harm (patient data mismatch) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 492 units of the RAPIDPoint 400 Blood Gas Analyzer. The recall affects units with specific Siemens Material Numbers (SMN) and all serial numbers. The devices were distributed nationwide and to numerous foreign countries.
The recall is due to a 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 the name fields have been turned off for the system. This potential for data mismatch could lead to incorrect patient identification in clinical settings.
Healthcare facilities and users of these devices should contact Siemens Healthcare Diagnostics Inc for further instructions on how to address the issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381 , 10339634
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 492
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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