Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor.
FDA device recall Z-0523-2007 · posted 2007-02-27 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Incorporated
- Reason for recall
- Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and Sp02 alarm limits being frozen. This can result in delay in treatment.
- Action taken
- On 1/3/07 the firm issued a letter to their customers advising of the issues and provided guidance to the consignee to enable the Check Setup feature that will provide an audible prompt whenever the monitor resets. The letter advises that consignees will be contacted to schedule an update, once new software has been validated.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 1347 devices; 1067 domestic and 280 international
- Distribution
- Nationwide and worldwide.
- Date initiated
- 2007-01-03
- Date posted
- 2007-02-27
- Date terminated
- 2011-02-15
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 (K050605) | Spacelabs Medical, Inc. | 2005-05-03 |