Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 4, 2013
ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attache…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics recalled ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 1… - a moderate-severity action.
ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 1… was recalled by Siemens Healthcare Diagnostics in September 4, 2013. Reason: The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cov…. Check the official notice for the remedy. Verify recall #Z-2114-2013 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics issued this moderate-severity FDA Devices recall-The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cov….
- Moderate
- severity level
- Class II
- classification
- September 4, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2114-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2114-2013) was formally reported on September 4, 2013, with the manufacturer initiating the action on June 26, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Healthcare Diagnostics is listed as the recalling firm, operating out of Tarrytown, NY. Federal records list the affected scope as Domestic: 950 units; Foreign: 3369 units.
The documented reason for this recall is: The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sid… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and the countries of Austria, Australia, Belgium, Bosnia - Herzegovina, China, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, Indi…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Domestic: 950 units; Foreign: 3369 units
Related Recalls
6
3 from same agency
Product description
ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
Reason for recall
The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides. Over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. This could cause the cover to fall during maintenance procedures.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2114-2013 |
| Date reported | September 4, 2013 |
| Date initiated | June 26, 2013 |
| Recalling firm | Siemens Healthcare Diagnostics |
| Firm location | Tarrytown, NY |
| Affected scope | Domestic: 950 units; Foreign: 3369 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Austria, Australia, Belgium, Bosnia - Herzegovina, China, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Irelan… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2114-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.. Recalled by Siemens Healthcare Diagnostics. Units affected: Domestic: 950 units; Foreign: 3369 units.
Why was this product recalled? ▼
The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides. Over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. This could cause the cover to fall during maintenance procedures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2013. Severity: Moderate. Recall number: Z-2114-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Austria, Australia, Belgium, Bosnia - Herzegovina, China, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Ireland, Iraq, Israel, Italy, Japan, Kenya, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Martinique, Malaysia, Netherlands, Norway, New Zealand, Philippines, Poland, Portugal, Romania, Russian Republic, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom and Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2114-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 4, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.