Siemens RAPIDLab 1240 Blood Gas Analyzer Recalled for Patient Data Mismatch
Siemens is recalling 144 RAPIDLab 1240 Blood Gas Analyzers because patient names may be printed with data from a different patient.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 where a data integrity error could lead to incorrect patient treatment, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 144 units of the RAPIDLab 1240 Blood Gas Analyzer (Siemens Material Numbers 10321840, 10491392). The recall covers all serial numbers and includes units distributed nationwide and in numerous foreign countries.
The recall is being issued because there is a potential for the first and/or last name of one patient to be printed with the Patient ID and result data from a different patient. This error can occur even though those specific fields have been turned off for the system.
Healthcare facilities that have purchased or are using these analyzers should contact Siemens Healthcare Diagnostics Inc for further instructions on how to address the issue.
The recalled product
- Product
- Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 144
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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