Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0597-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Atellica CI Analyzer. Catalog Numbers: 10947347.

Product Classification:

Class II

Date Initiated: November 4, 2024

Date Posted: December 11, 2024

Recall Number: Z-0597-2025

Event ID: 95644

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 559 units

Code Information:

UDI-DI Number: 630414229560; Catalog Number: 10947347. Software version 1.28.51

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated