Recall Z-1577-2015— Spacelabs Healthcare Inc

Name: FDA recall Z-1577-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-21

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2015-04-21, terminated 2015-11-16. It names one FDA 510(k) clearance: K103142. Product: 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.. Reason: 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..

Recalling firm: Spacelabs Healthcare Inc
Classification: Class II
Status: Terminated
Initiated: 2015-04-21
Terminated: 2015-11-16
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, 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.

Reason for recall

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.

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