Z-2802-2016Class II

RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394

Name: Z-2802-2016 RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
Creator: Siemens Healthcare Diagnostics Inc
Published: 2016-08-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-08-11 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics Inc began a recall of RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394 on 2016-08-11. FDA classified it as Class II and gives the reason as "There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2802-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-11
Posted: 2016-09-14
Terminated: 2020-07-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
Root cause tag: software
FDA root cause: Software design
Action: Siemens Healthcare issued Urgent Field Safety Notice to (US) customers via Federal Express. . All affected customers outside the US provided a copy of an Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. This notice informs customers of the issue, Actions to be Taken by the Customer and to return the response form. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative
Quantity in commerce: 114 units
Distribution: Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Ivory Coast Japan Kazakhstan Kenya Kuwait Latvia Lebanon Lesotho Lithuania Luxembourg Macedonia Malaysia Mexico Netherlands New Caledonia New Zealand Norway P.R. China Peru Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Romania Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan U.A.E. United Kingdom Uruguay Vatikancity Vietnam
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2802-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2797-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-14
Z-2798-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-14
Z-2799-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-14
Z-2800-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-14
Z-2801-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-14
Z-2802-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-14
Z-2803-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-14

Product code CHL

K073537Class INeonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics / cleared 2008-06-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)