Food, drugs, devices › Siemens Medical Solutions Diagnostics
Device recall: VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to
Siemens Medical Solutions Diagnostics (Flanders, NJ) initiated this device recall on 25 Apr 2014; FDA lists 1 product record under event 68320, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 16 Apr 2015. Initiation: voluntary: firm initiated. Siemens Medical Solutions Diagnostics has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Siemens Medical Solutions Diagnostics, Flanders, NJ.
Reason for recall
"The keyboard and monitor may not be properly secured to the monitor arm."
Distribution
"Worldwide Distribution - USA including Iowa and New York and Internationally to Canada, Chile, France, India, Italy, Malaysia, Peru, Korea, and the United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1832-2014 | VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results. | 19 units | Class III | Terminated | 25 Jun 2014 |
Context
Other enforcement events for Siemens Medical Solutions Diagnostics
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Mar 2015 | Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instrume | Device | Class II | 6 |
| 3 Feb 2014 | IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perfo | Device | Class II | 1 |
All 3 events for Siemens Medical Solutions Diagnostics
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The keyboard and monitor may not be properly secured to the monitor arm."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA including Iowa and New York and Internationally to Canada, Chile, France, India, Italy, Malaysia, Peru, Korea, and the United Kingdom."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Apr 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.