Recall Z-0517-06 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Spacelabs Medical Incorporated
Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient''s ventilatory, circulatory, and metabolic status.
| Date | Feb 16, 2006 (initiated Jul 20, 2005) |
| Status | Terminated |
| Reason | The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. The module will not compensate for pressure changes and CO2 readings will be inaccurate at higher altitudes. |
| Root cause | Other |
| Action | On 7/20/05 Spacelabs called the consignees that received the units to notify them of the hazard and also the schedule a service call to repair the affected capnography modules. The firm will confirm that all consignees have been updated with the appropriate PCBA and will audit the device recall records for completion. |
| Quantity | 11 units |
| Distribution | 8 units shipped to France, 1 unit to Brussels, Belgium, and 2 units to a medical center in WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031124 | POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR Datex-Ohmeda, Inc., Dec 4, 2003 |