FDA Medical Device Recalls (openFDA)
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 number
- Z-0517-06
- Recalling firm
- Spacelabs Medical Incorporated
- 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.
- Status
- Terminated
- Initiated
- 2005-07-20
- Posted
- 2006-02-16
- Terminated
- 2006-02-17
- 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.
- Lot, serial or model codes
- Model 91517 Lot BMP007559
- 510(k) numbers
- ["K031124"]
- PMA numbers
- not on file
- Product code
- CCK
- Firm FEI
- 3010157426
- Firm city
- Issaquah
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28