Siemens RAPIDLab 1265 Blood Gas Analyzer Recalled for Data Mismatch
Siemens is recalling RAPIDLab 1265 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 involves a risk-of-harm product (medical device) where a data mismatch could lead to incorrect patient care, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 2,602 units of the RAPIDLab 1265 Blood Gas Analyzer (Siemens Material Numbers 10321852, 10470366, 10491395). The recall covers all serial numbers and includes units distributed nationwide and in numerous foreign countries.
The recall is due to a potential software error 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 issue can occur even when those specific fields have been turned off for the system.
Healthcare facilities should contact Siemens Healthcare Diagnostics Inc for instructions on how to address the issue. The source text does not specify a particular action for individual consumers, as the product is a medical device used in clinical settings.
The recalled product
- Product
- RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 2,602
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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