Atellica CI Analyzer. Catalog Numbers: 10947347 recallZ-0597-2025 · Siemens Healthcare Diagnostics, Inc. · initiated Nov 4, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.
FDA root cause category: Software design
Recall details
- Recall number
- Z-0597-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 4, 2024
- Posted by the FDA
- Dec 4, 2024
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 559 units
- Product code
- JJE
- FDA submissions
- K222116
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Bangladesh, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Malaysia, Netherlands, Oman, Pakistan, Paraguay, Peru, Philippines, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom Great Britain, Vietnam.
Product description
Atellica CI Analyzer. Catalog Numbers: 10947347.
Code information (models, lots, serial numbers)
UDI-DI Number: 630414229560; Catalog Number: 10947347. Software version 1.28.51
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Atellica CI Rack Handler 10947348Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K222116 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Atellica CI Analyzer 10947347Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE12 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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