Siemens Atellica Sample Handler Prime Software Update Recall

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Contact the company & request your remedy

Recalling firmSiemens Healthcare Diagnostics, Inc.511 Benedict Ave, N/A · Tarrytown, NY 10591-5005

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Siemens Healthcare is recalling the Atellica Sample Handler Prime device with Material Number 11069001 because of software issues that need updating. This recall does not pose a risk of injury to users.

Why it’s dangerous

The system software has multiple issues that require an update. These issues could lead to improper device operation if not addressed, but the recall does not mention any risk of injury.

Who’s affected

Users of the Atellica Sample Handler Prime device with Material Number 11069001 are affected. Laboratory staff and healthcare professionals using this device are most at risk.

How to tell if you have this one

Check for the Material Number 11069001 on the device. The device was sold with a UDI (Unique Device Identification) of 00630414002026.

Brand
Siemens Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Software
Verify if your Atellica Sample Handler Prime has the software update required by the recall.

✎ GovInfoNow

Questions people ask

Is there a risk of injury from this device?

The recall states there are software issues requiring an update, but no risk of injury is mentioned.

How do I know if my device is affected?

Check for Material Number 11069001 on the device or the UDI 00630414002026.

Do I need to stop using the device immediately?

No, the recall does not require immediate stop use; software updates are needed.

Take action

Contact Siemens Healthcare

We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1301-2019 — Siemens Healthcare Siemens Healthcare

Hello,

I own a Siemens Healthcare that is covered by recall Z-1301-2019 from Siemens Healthcare.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

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-1301-2019 (March 7, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1301-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

Siemens Healthcare Diagnostics, Inc. recalls Atellica Sample Handler Prime, Material Number 11069001

Lower-risk recall