Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Atellica IM 1600 Analyzer Recalled by Siemens Healthcare Diagnostics, Inc. Due to There were multiple issues identified in the system...

Date: March 7, 2019
Company: Siemens Healthcare Diagnostics, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.

Affected Products

Atellica IM 1600 Analyzer, Material Number 11066000

Quantity: 366

Why Was This Recalled?

There were multiple issues identified in the system software which required an update.

Where Was This Sold?

This product was distributed to 35 states: AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NM, NY, NC, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY

Affected (35 states)Not affected

About Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report