Spacelabs Healthcare Inc recalls Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Mo…

Recall date

April 21, 2015

Source

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

Recall number

Z-1577-2015

FDA classification

Class II

Brand / firm

Spacelabs Healthcare Inc

Sold / distributed

Worldwide Distribution:US (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IA, ID, IL, LA, ME, MI, MN, MO, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, WY, and Puerto Rico and countries of: Argentina, Australia, Bangladesh, Canada, Chile, France, Great Britain, India, Kuwait, Panama, Poland…

Why it was recalled

Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R) and the Masimo SpO2 PCBA, PN: 010-1136-02. With these two options and the Masimo SpO2 PCBA present, the module may experience random resets.

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, with the Masimo SpO2 PCBA, PN: 010-1636-02. 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.