Siemens RAPIDLab 1245 Blood Gas Analyzer Recalled for Data Mismatch
Siemens is recalling 197 RAPIDLab 1245 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 (medical device) where incorrect patient data could lead to clinical errors, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 197 units of the RAPIDLab 1245 Blood Gas Analyzer. The affected units are identified by Siemens Material Numbers 10321844, 10337179, and 10491393, and the recall applies to all serial numbers. The devices were 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 should contact Siemens Healthcare Diagnostics Inc for instructions on how to resolve the issue. No specific consumer action is required for the general public, as these devices are used in clinical settings.
The recalled product
- Product
- RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 197
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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