Z-0517-06

Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer designed to measure the...

Name: Z-0517-06 Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer designed to measure the...
Creator: Spacelabs Medical Incorporated
Published: 2005-07-20
License: https://open.fda.gov/license/

GE Healthcare / initiated 2005-07-20 / Terminated

FDA source

Spacelabs Medical Incorporated began a recall of Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture... on 2005-07-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0517-06
Status: Terminated
Initiated: 2005-07-20
Posted: 2006-02-16
Terminated: 2006-02-17
Recalling firm: GE Healthcare
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.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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.
FDA 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 in commerce: 11 units
Distribution: 8 units shipped to France, 1 unit to Brussels, Belgium, and 2 units to a medical center in WY.
Product codes and lots: Model 91517 Lot BMP007559

Product code CCK

K031124Class IIPolaris 95000-a Bedside/transport MonitorDatex-Ohmeda, Inc. / cleared 2003-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)