Recall Z-0115-2007 ยท JQP Calculator/Data Processing Module, For Clinical Use
Radiometer America Inc
Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer
| Date | Oct 28, 2006 (initiated Jul 6, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 Valley Medical Center, Vail, CO (2 units). World wide accounts pending submission. Three (3) Canadia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050869 | MODIFICATION TO ABL800 FLEX Radiometer Medical Aps, Aug 11, 2005 |