Spacelabs Healthcare Inc recalls Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-p…

Recall date

April 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1542-2015

FDA classification

Class II

Brand / firm

Spacelabs Healthcare Inc

Sold / distributed

Worldwide Distribution- US Nationwide in the states of AL, DE, GA, ID, IL, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, VA, WA and the country of France.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.