Company: Spacelabs Healthcare Inc
Date of Enforcement Report: 5/13/2015
Class lI:
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. Recall Number Z-1577-2015
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/MANUFACTURER
Spacelabs Healthcare Inc,. Snoqualmie, WA on 4/21/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
1944 units
DISTRIBUTION
Nationwide and Internationally
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