Siemens Blood Analysis System Software Malfunction May Cause Patient Identification Error
Siemens epoc NXS Host blood analysis systems are recalled due to a software malfunction that can assign incorrect patient names to blood tests, potentially leading to misdiagnosis or mistreatment.
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: This is a Class II recall of a risk-of-harm medical device where no illnesses or injuries have been reported. The software malfunction creates potential for serious patient harm through misdiagnosis or mistreatment if wrong patient identification is not caught, meeting the rubric criterion for High severity.
Plain-English summary
The Siemens epoc NXS Host is a blood analysis system intended for use by trained medical professionals in laboratory and point-of-care settings. The device performs quantitative testing of heparinized or un-anticoagulated arterial, venous, or capillary blood samples.
Siemens Healthcare Diagnostics is recalling the device due to a software malfunction in version 4.14.9. Under specific conditions, if a user does not ensure verification of the correct patient name, the device can assign an incorrect patient name to a blood measurement. This incorrect patient identification can be saved with the test result.
The software malfunction has the potential to impact patient safety through misdiagnosis and/or mistreatment by clinicians if the wrong patient information is used to interpret or act on the test result. The device is distributed nationwide and internationally.
The recalled product
- Product
- epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1
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 (3)
- Siemens Material Number: 11413517
- UDI-DI: 00630414605838
- Software Version Number: 4.14.9.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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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