Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 8, 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.
D50 and D51 Diagnostic error codes are not functional.
Siemens Healthcare Diagnostics, Inc recalled The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gas… — a moderate-severity action.
The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gas… was recalled by Siemens Healthcare Diagnostics, Inc in July 8, 2015. Reason: D50 and D51 Diagnostic error codes are not functional.. Check the official notice for the remedy. Verify recall #Z-1961-2015 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc issued this moderate-severity FDA Devices recall — D50 and D51 Diagnostic error codes are not functional..
- Moderate
- severity level
- 122 units
- affected scope
- Class II
- classification
- July 8, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1961-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1961-2015) was formally reported on July 8, 2015, with the manufacturer initiating the action on May 6, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Healthcare Diagnostics, Inc is listed as the recalling firm, operating out of East Walpole, MA. Federal records list the affected scope as 122 devices.
The documented reason for this recall is: D50 and D51 Diagnostic error codes are not functional. Distribution data in the federal record shows the product reached: Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Bosnia, Herzog,Brazil, Brunei, Canada, Chile, Colombia, Croatia, Czech Republic, E…. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
122 devices
Related Recalls
6
6 from same agency
Product description
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.
Reason for recall
D50 and D51 Diagnostic error codes are not functional.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1961-2015 |
| Date reported | July 8, 2015 |
| Date initiated | May 6, 2015 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Firm location | East Walpole, MA |
| Affected scope | 122 devices |
| Distribution | Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Bosnia, Herzog,Brazil, Brunei, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, Franc… |
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-1961-2015) 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? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 122 devices.
Why was this product recalled? ▼
D50 and D51 Diagnostic error codes are not functional.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2015. Severity: Moderate. Recall number: Z-1961-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Bosnia, Herzog,Brazil, Brunei, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany,Georgia, Greece, Hong Kong, Iceland, India, Indonesia, Ireland, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, P.R. China, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Venezuela and Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1961-2015) 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.
Continue exploring
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What to do next
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 8, 2015.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.