Z-0781-2019Class II

Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens -

Name: Z-0781-2019 Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens -
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-09-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-09-26 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro... on 2018-09-26. FDA classified it as Class II and gives the reason as "Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample Handler Prime". 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-0781-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-26
Posted: 2019-01-29
Terminated: 2020-06-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Siemens Material Number (SMN) :11066000
Product code: JIT Calibrator, Secondary
Reason for recall: Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample Handler Prime
Root cause tag: software
FDA root cause: Software design
Action: Siemens Healthcare Diagnsotics issue an Urgent Medical Device Correction (UMDC) was issued to US customers via Fed-Ex on September 26, 2018. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities. The letter explains the reasons, observed behaviors, risk to health, actions to be taken. Review the letter with the Medical Director. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. The system will be updated with software version- SW V1.15 which resolves issues.
Quantity in commerce: 264
Distribution: Worldwide distributions - US Nationwide and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Poland, Portugal, Republic Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, U.A.E., United Kingdom, Vietnam.
Product codes and lots: Software in V 1.14.2 and lower.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0781-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0780-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-29
Z-0781-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-29
Z-0782-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-29
Z-0783-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-29

Product code JIT

K151792Class IITrinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) SystemSiemens Healthcare Diagnostics, Inc. / cleared 2015-11-20

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)