Recall Z-1325-06 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
| Date | Aug 3, 2006 (initiated Oct 31, 2005) |
| Status | Terminated |
| Reason | ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched. |
| Root cause | Other |
| Action | The firm initiated this recall on 10/31/2005, at which time a Field Action Note was issued to their Service Reps. The notice instructed the service personnel to upgrade all ABL800 analyzer units presently running with software version V5.21 to the new version V5.23, in order to correct this problem. The Service Personnel began conducting visits at each customer site on 10/31/2005. |
| Quantity | 36 |
| Distribution | Worldwide, including USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041874 | ABL800 FLEX Radiometer Medical Aps, Oct 8, 2004 |