Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Data Mismatch
Siemens Healthcare Diagnostics Inc is recalling 6,786 RAPIDPoint 500 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. The hazard involves a risk of harm (data mismatch leading to potential misdiagnosis or treatment errors) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 6,786 units of the Siemens RAPIDPoint 500 Blood Gas Analyzer (SMN: 10492730, 10696855, 10696857, 10697306). The recall covers all serial numbers and includes units distributed nationwide and in numerous foreign countries.
The recall is due to a potential 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, even when those fields have been turned off for the system. This discrepancy could lead to confusion regarding patient identity and test results.
Healthcare facilities and users of these devices should contact Siemens Healthcare Diagnostics Inc for instructions on how to resolve the issue. The source text does not specify a specific action for consumers, as the product is a medical device used in professional settings.
The recalled product
- Product
- Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 6,786
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.
See all 7 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics Inc
See all →- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · data integrity
See all →- ModerateVentana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies
FDA (Devices) · 2026-08-19
- SevereGE Healthcare MAC VU360 Electrocardiograph Software Recall
FDA (Devices) · 2026-08-12
- SevereCopan WASPLab Software Recall Over Results Overwrite Issue
FDA (Devices) · 2026-08-12
- SevereMedline spinal anesthesia trays recalled over Huons bupivacaine quality concerns
FDA (Devices) · 2026-06-03
- SevereMedline pain and Whitacre spinal trays recalled over bupivacaine concerns
FDA (Devices) · 2026-06-03