FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: 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.
- Recall number
- Z-1962-2015
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2015-05-06
- Posted
- 2015-07-02
- Terminated
- 2017-08-02
- Reason
- D50 and D51 diagnostic error codes are not functional.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 2713 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, 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.
- Lot, serial or model codes
- Siemens Material Number (SMN): 10321852, 10470366, 10491395, 10335524
- 510(k) numbers
- ["K073537"]
- PMA numbers
- not on file
- Product code
- CGA
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28