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Terminated

RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730, 10696857, 10697306

FDA Recall Z-2040-2017 · Posted None

Recalling FirmSiemens Healthcare Diagnostics Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2017-04-10
Date Terminated2019-08-20
Product Quantity159 units

Reason for Recall

Potential Patient Demographic Error with Blank Patient ID Field

Firm Action

Siemens Healthcare issued an An Urgent Field Safety Notice via e-mail to all affected Siemens Healthcare Diagnostics Regional offices on April 10, 2017 both in the United States and outside of the United States. This notice informs customers of the issue, risk to health and actions to be taken by the customer. A Field Correction Effectiveness Check form to be completed and returned. Questions: Contact your Siemens Customer Care Center or your local Siemens technical support representative

Root Cause

Software design

Distribution Pattern

Nationwide Foreign: Australia Bangladesh Chile Colombia France Germany Hong Kong India Ireland Japan Latvia Mexico Spain Switzerland Thailand Uruguay

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113216RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare Diagnostics · 2012-05-03K031560BAYER RAPIDLAB 1200 SYSTEMBayer Healthcare, LLC · 2003-12-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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