Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer
FDA device recall Z-0115-2007 · posted 2006-10-28 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- Incorrect FI02 values: programming issue can cause incorrect values to be transmitted to the LIS when : 1)- The FIO2 result is edited in the manual sample processing mode--2)- An existing result is opened and FI02 is then edited and sent.....In both cases RADIANCE will transmit the original FI02 value, not the value that was edited.
- Action taken
- The recalling firm initially contacted their customers and informed them of the software problem and the upcoming field correction for the software, via telephone on 7/6/2006. A follow-up letter dated 7/21/2006, was also sent to the customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 5 units
- Distribution
- Worldwide-The six USA units (equpped with Radiance software) were distributed to a total of two (2) U.S. customers: University of Missouri Hospitals and Clinics in Columbia, MO (4 units) and Vail Vall
- Date initiated
- 2006-07-06
- Date posted
- 2006-10-28
- Date terminated
- 2011-11-18
- Location
- Westlake, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ABL800 FLEX (K050869) | Radiometer Medical Aps | 2005-08-11 |