Siemens RAPIDLab 1260 Blood Gas Analyzer Recalled for Data Mismatch
Siemens is recalling 114 RAPIDLab 1260 Blood Gas Analyzers because patient names may be printed with data from different patients.
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 high-risk medical device where a data integrity error could lead to incorrect patient identification or treatment, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 114 units of the RAPIDLab 1260 Blood Gas Analyzer (Siemens Material Numbers 10321846, 10491394). 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 the name fields have been turned off for the system.
Healthcare facilities using these devices should contact Siemens Healthcare Diagnostics Inc for further instructions on how to address the potential data mismatch.
The recalled product
- Product
- RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 114
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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