Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management 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 ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.

Spacelabs Healthcare sent an Urgent - Medical Device Correction letter, dated 17 April 2015, to the US consignees via priority mail. On 4/24/2015, the firm will send the Urgent - Medical Device Correction letter (translated as necessary) via email to international subsidiaries and distributor of record. The Identified the affected product, problem and actions to be taken. Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M are affected. Ultraview SL Command Modules originally shipped with Masimo SpO2 are NOT affected. Spacelabs Healthcare will contact you to schedule a convenient time for Spacelabs to correct all of your facility's affected Command Modules at no cost. For additional information or technical assistance, please contact: Technical Support Spacelabs Healthcare, Inc. 35301 SE Center St. Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support