Ultraview SL Command Module, Model 90496 The product is intended for use with the Patient Care Monitoring System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include cardiac activity, respiration, invasive and noninvasive pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
FDA Recall Z-2342-2008 · Posted 2008-09-19
Recalling FirmSpacelabs Healthcare, Incorporated
Recall StatusTerminated
Product CodeDSI
Date Initiated2008-07-22
Date Terminated2011-07-25
Product Quantity5,140
Reason for Recall
Potential for module to fail to obtain a NIBP reading on hypertension patients.
Firm Action
On July 22, 2008 an "Urgent MEDICAL DEVICE CORRECTION" letter was mailed to all the firm's customers. The letter states the problem at hand, when the problem would likely to occur and instructions of a way to mitigate the risk, until the modules can be recalibrated . The firm's Customer Connectivity Center will confirm all affected customers have been notified. Spacelabs Technical Support will be recalibrating all modules personally and ensuring all corrections have been applied to all affected customers of record. Contact Spacelabs Healthcare at 1-800-522-7025 for assistance.
Root Cause
Process control
Distribution Pattern
The product is distributed nationwide and internationally to medical facilities.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.