FDA-Device2012-11-14Class II
The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules.
Spacelabs Healthcare, Llc
Hazard
Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation.
Sold states
Worldwide Distribution--US (nationwide) including states of Alaska, California, Florida, Illinois, Michigan, South Carolina, and Texas., and the countries of Canada, Chile, France, Libya, Panama, Qatar, Saudi Arabia, Switzerland and United Kingdom
Affected count
169 units distributed (98 in US and 71 Internationally)
Manufactured in
5150 220th Ave Se, N/A, Issaquah, WA, United States
Products
The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0196-2013Don't want to check this manually?
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