Recall Z-1542-2015— Spacelabs Healthcare Inc

Name: FDA recall Z-1542-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-17

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2015-04-17, terminated 2015-11-13. It names one FDA 510(k) clearance: K103142. Product: 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.. Reason: 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..

Recalling firm: Spacelabs Healthcare Inc
Classification: Class II
Status: Terminated
Initiated: 2015-04-17
Terminated: 2015-11-13
Firm location: Snoqualmie, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K103142 — SPACELABS MULTI-PARAMETER MODULESpacelabs Healthcare, Inc.·cleared 2011-03-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.