Food, drugs, devices › Siemens Healthcare Diagnostics, Inc
Device recall: The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites a
FDA enforcement event 71073 is a device recall by Siemens Healthcare Diagnostics, Inc of East Walpole, MA, initiated 6 May 2015 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 2 Aug 2017. Initiation: voluntary: firm initiated. Siemens Healthcare Diagnostics, Inc has 333 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 Healthcare Diagnostics, Inc, East Walpole, MA.
Reason for recall
"D50 and D51 Diagnostic error codes are not functional."
Distribution
"Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Bosnia, Herzog,Brazil, Brunei, Canada, Chile, Colombia,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1961-2015 | The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples. | 122 devices | Class II | Terminated | 8 Jul 2015 |
| Z-1962-2015 | The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples. | 2713 devices | Class II | Terminated | 8 Jul 2015 |
Context
Other enforcement events for Siemens Healthcare Diagnostics, Inc
All 333 events for Siemens Healthcare Diagnostics, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "D50 and D51 Diagnostic error codes are not functional."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Bosnia, Herzog,Brazil, Brunei, Canada, Chile, Colombia,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Aug 2017. "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.