RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or ...

FDA Device Recall #Z-2040-2017 — Class II — April 10, 2017

Recall Summary

Recall Number Z-2040-2017
Classification Class II — Moderate risk
Date Initiated April 10, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Healthcare Diagnostics Inc
Location Norwood, MA
Product Type Devices
Quantity 159 units

Product Description

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

Reason for Recall

Potential Patient Demographic Error with Blank Patient ID Field

Distribution Pattern

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

Lot / Code Information

Serial Numbers: 30762 32470 33999 35395 36284 39672 40405 40456 40508 30779 33198 34000 35462 37243 39688 40406 40460 40509 30784 33201 34082 35688 37261 39689 40407 40461 40510 30819 33232 34083 35690 37275 39690 40408 40464 40512 30841 33370 34291 35692 37292 39691 40409 40466 40561 30842 33438 34427 35693 37295 39692 40410 40467 40562 30844 33459 34438 35703 37296 39693 40411 40468 40565 30846 33573 34442 35705 37563 39694 40412 40469 40568 30904 33640 34444 35922 38110 39695 40413 40470 40576 30905 33643 34627 36003 38138 39698 40421 40471 40580 30906 33863 35002 36005 38306 39699 40422 40473 40582 30907 33865 35009 36006 38815 39700 40427 40477 40583 31006 33968 35053 36007 39301 39701 40436 40489 40594 31771 33986 35055 36008 39303 39702 40437 40501 40596 31772 33997 35195 36113 39459 39703 40448 40502 40612 32356 33998 35393 36116 39597 40403 40451 40503 40616 40624 40625 40642 40643 40644 40647 40648 40666 40669 40677 40678 40679 40748 40806 313388

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.