Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer designed to measure the concentrat
FDA device recall Z-0517-06 · posted 2006-02-16 · Terminated
Recall details
- Recalling firm
- Spacelabs Medical Incorporated
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 11 units
- Distribution
- 8 units shipped to France, 1 unit to Brussels, Belgium, and 2 units to a medical center in WY.
- Date initiated
- 2005-07-20
- Date posted
- 2006-02-16
- Date terminated
- 2006-02-17
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR (K031124) | Datex-Ohmeda, Inc. | 2003-12-04 |