# FDA recall Z-2214-2024

> **Siemens Healthcare Diagnostics Inc** · Class II · device recall initiated 2024-05-17.

## Product

Software version 5.3 in:   RAPIDPoint 500e Blood Gas System (USA)  Siemens Material Number:  11416751    RAPIDPoint 500e Blood Gas System (China) 11416752;  RAPIDPoint 500e Blood Gas System (Japan) 11416754;  RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;

## Reason for recall

Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.

## Distribution

Worldwide - US Nationwide distribution in the states of FL, GA, LA, MI, NC and the countries of Chile, Costa Rica, France, Germany, Japan, Lebanon, Mexico, Netherlands, New Zealand, Poland, Spain, Turkey, United Kingdom.

## Key facts

- **Recall number:** Z-2214-2024
- **Recalling firm:** Siemens Healthcare Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-17
- **Report date:** 2024-07-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norwood, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2214-2024

## Citation

> AI Analytics. FDA recall Z-2214-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2214-2024. Source: US FDA. Licensed CC0.

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