Lower riskMedical device recall · FDA · Published December 2, 2020
Siemens Atellica IM 130: Software issues may cause inaccurate test results
Siemens Healthcare recalls Atellica IM 1300 analyzers with software v1.23.2 or lower that may report inaccurate patient test results. Affected units include those with specific material numbers.
“Siemens Atellica IM 130: Software issues may cause inaccurate test results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63726-siemens-atellica-im-130-software-issues-may-cause-inaccurate-test. Based on FDA recall #Z-0862-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0862-2021%22&limit=1).
The FDA announced on Dec. 2, 2020, that Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version V1.23.2 or lower due to potential discrepant patient results. The agency classified the recall as Class II.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica IM 1300 Analyzer
Siemens Material Number (SMN): 11066001
Software versions: V1.23.2 or lower
The hazard
Multiple issues in the affected software may lead to the reporting of discrepant patient results during in vitro diagnostic testing of clinical specimens.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Siemens Atellica CH RCRP Test (Aug. 17, 2026), Beckman Coulter Emit 2000 Quinidine Assay (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Additional recent recalls include Roche cobas pro integrated solutions (Jan. 20, 2026), DxC 500i Clinical Analyzer Modules (Sept. 2, 2026), and Siemens CT Software Applications (Dec. 19, 2025).
How to tell if you have this one
Check if your Atellica IM 1300 analyzer has software version 1.23.2 or lower. The product uses Siemens Material Number (SMN) 11066001.
Brand
Siemens Healthcare
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed. Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E. Ukraine, United Kingdom, Uruguay, Vatika City, Vietnam.
Recall number
Product, codes & lots
Quantity
Z-0861-2021
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.; Software (SW) versions V1.23.2 (SMN 11469032) or lower
2405 units
Z-0862-2021
Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.; Software (SW) versions V1.23.2 (SMN 11469032) or lower
1095 units
Z-0863-2021
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.; Software (SW) versions V1.23.2 (SMN 11469032) or lower
1588 units
Based on the official FDA remedy
What to do — step by step
Update Software
Contact Siemens Healthcare to update the software to version 1.23.3 or higher.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0862-2021 (December 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0862-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.