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.
Recall
- Recall Number
- Z-0517-06
- Event Number
- 32815
- Firm
- Spacelabs Medical Incorporated
- FEI Number
- 3010157426
- Product Code
- CCK
- Status
- Terminated
- Root Cause
- Other
- Initiated
- July 20, 2005
- Posted
- February 16, 2006
- Terminated
- February 17, 2006
- Address
- 5150 220th Ave Se, Issaquah, WA, 98029-6834
Description
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.
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.
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.
8 units shipped to France, 1 unit to Brussels, Belgium, and 2 units to a medical center in WY.
11 units