ClearanceBrief
Recall Z-1577-2015 ยท DSI Detector And Alarm, Arrhythmia

Spacelabs Healthcare Inc

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.

DateMay 4, 2015 (initiated Apr 21, 2015)
StatusTerminated
ReasonModules 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.
Root causeSoftware design
ActionSpacelabs expanded the recall to include additional 29 units and notified one additional new consignee on June 4, 2015. ******************************************************************************************* The firm, Spacelabs Healthcare, sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated 27 April 2015, via priority mail to US consignees and email to foreign consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to circulate this notification to all persons concerned by the information it contains; add a copy to the appropriat
Quantity1973 units total (1345 modules in the US and 604modules international and 3 PCBAs in US and 21 PCBAs international)
DistributionWorldwide 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
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K103142SPACELABS MULTI-PARAMETER MODULE
Spacelabs Healthcare, Inc., Mar 3, 2011