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Spacelabs Healthcare Inc recalls Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter
Recalled May 13, 2015 · FDA recall Z-1577-2015 · Spacelabs Healthcare
Hazard
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. · FDA Class II
Units
1973 units total (1345 modules in the US and 604modules international and 3 PCBAs in US and 21 PCBAs international)
Sold at
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, Qatar, Saudi Arabia, and Turkey. .
Description
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.
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.
Manufacturer(s)
Spacelabs Healthcare Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →