FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics: RapidLab 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division
- Recall number
- Z-1464-06
- Recalling firm
- Siemens Healthcare Diagnostics
- Product
- RapidLab 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division
- Status
- Terminated
- Initiated
- 2006-04-04
- Posted
- 2006-08-29
- Terminated
- 2012-07-30
- Reason
- Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab 1245 or RapidLab 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink, or Rapidcomm data management system.
- Root cause
- Software design
- Action
- On 4/04/06, Bayer HealthCare LLC (Diagnostics Division) sent Support Bulletins to all affected Bayer HealthCare LLC Branches via e-mail in order to inform them of the issue, and to provide them with instructions for the interim work-around until the new software version is installed. Customer Bulletins were prepared and sent to the Branches both in the United States and globally for communication with the affected customers.
- Quantity
- Domestic - 124 units, Foreign-364 units (all systems)
- Distribution
- Worldwide
- Lot, serial or model codes
- Part No. 05061537; all units using Version 1.0, 1.01, or 1.02 software connected to LIS, Rapidlink¿, or Rapidcomm data management systems.
- 510(k) numbers
- ["K031560"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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