The Rapidlab 1260 system is a blood gas analyzer used for… recallZ-1961-2015 · Siemens Healthcare Diagnostics, Inc · initiated May 6, 2015
Class II Terminated All recalls posted in July 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
D50 and D51 Diagnostic error codes are not functional.
FDA root cause category: Software design
What the company is doing
Siemens sent an Urgent Field Safety Notice April 2015, to all affected customers. Customers were notified of the recall beginning on May 6, 2015 via Federal Express. Foreign customers were notified starting on May 5, 2015 via method determined by each countries local regulations and procedures. The notification informs customers of the issue and asks customers to do the following: Ensure that the Glucose and Lactate sensor contacts are aligned and completely seated with the contacts on the analyzer, Analyze a minimum of 2 levels of quality control material after installing the sensors, as indicated in the RAPIDLab 1200 Operator's Guide, Review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 7 days. Retain this letter with your laboratory records, and forward this letter to those who may have received this product. For further questions please call (800) 242-3233.
Recall details
- Recall number
- Z-1961-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 6, 2015
- Posted by the FDA
- Jul 2, 2015
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 122 devices
- Product code
- CGA
- FDA submissions
- K031560
- 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.
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.
Code information (models, lots, serial numbers)
Siemens Material Number (SMN): 10321846, 10491394, 10339910
Other devices under the same FDA submission
2 devices cleared under K031560 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RAPIDLab® 1200 Series 1265 10321852Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION SPECIFIC, CALCIUM12 reports
- RAPIDLab® 1200 Series 1240 10321840Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION-SPECIFIC, CHLORIDE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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