RAPIDPOINT 500 Blood Gas System

FDA device recall Z-0423-2024 · posted 2023-12-01 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics Inc

Reason for recall

There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia may lead to iatrogenic hyponatremia, resulted in a delay in patient diagnosis and optimal patient management.

Action taken

The firm issued an Urgent Medical Device Correction notice on 9/26/2023 to customers asking that customers review the notice with the facility's Medical Director to determine the appropriate course of action for previously generated results, complete and return the Field Correction Effectiveness Check Form within 30 days, forward this notice to customers if your firm is a distributor, and retain the notification in your system's Operator's Guide and forward to those who may have received product. The Field Correction Effectiveness Check Form is to be returned via email to uscctsfcaecfax.team@siemens-healthineers.com or by fax to 312-275-7795. Questions are to be directed to your local Siemens Healthineers Technical Support Representative.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JGS

Quantity affected

12,363 units

Distribution

Domestic: Nationwide Distribution. Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswa

Date initiated

2023-09-26

Date posted

2023-12-01

Location

Norwood, MA

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