Z-2601-2016Class III

Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500...

Name: Z-2601-2016 Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500...
Creator: Siemens Healthcare Diagnostics Inc
Published: 2016-07-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-07-05 / Terminated

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a... on 2016-07-05. FDA classified it as Class III and gives the reason as "Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2601-2016
Classification: Class III
Status: Terminated
Initiated: 2016-07-05
Posted: 2016-08-19
Terminated: 2017-08-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed 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. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Product code: KHP Acid, Lactic, Enzymatic Method
Reason for recall: Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
FDA root cause: Under Investigation by firm
Action: Siemens sent a Customer Notification dated July 2016 to all affected domestic (US) customers via Federal Express on July 5, 2016. Customers were asked to take the following actions: Please do not use the dialysate mode. If you have enabled this feature, please disable it by following these instructions: 1. At the System screen, select Setup. 2. Select Secured Options > Analysis Options. 3. Unselect Dialysate. 4. Select the Continue button 3 times. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check attached to this letter within 7 days. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens Technical Support representative. For questions regarding this recall call 781-269-3000.
Quantity in commerce: 76
Distribution: Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
Product codes and lots: Software Version 2.2A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2601-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2601-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19

Product code KHP

K113216Class IRapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics / cleared 2012-05-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)