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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Spacelabs Medical Incorporated
Lot Codes / Batch Numbers
Model 91517 Lot BMP007559
Products Sold
Model 91517 Lot BMP007559
Spacelabs Medical Incorporated is recalling Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer designed to me due to The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. The module will not compensate fo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, WY
Page updated: Jan 10, 2026