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.
FDA Recall Z-0517-06 · Posted 2006-02-16
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Recalling FirmSpacelabs Medical Incorporated
Recall StatusTerminated
Product CodeCCK
Date Initiated2005-07-20
Date Terminated2006-02-17
Product Quantity11 units
Reason for Recall
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.
Firm 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.
Root Cause
Other
Distribution Pattern
8 units shipped to France, 1 unit to Brussels, Belgium, and 2 units to a medical center in WY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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