High FDA (Devices)·Z-0196-2013·Announced 2012-11-14

Spacelabs Healthcare Recalls Xprezzon Bedside Monitor Touchscreen Displays

Spacelabs Healthcare is recalling 169 Xprezzon bedside monitor touchscreen displays because alarm lights may fail to illuminate upon installation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential failure of alarm lights on a medical device, which poses a risk of harm if patient data is not properly monitored, although no specific injuries are reported in the source text.

Plain-English summary

Spacelabs Healthcare, LLC is recalling 169 units of the touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393). The recall involves 98 units distributed in the United States and 71 units distributed internationally.

The recall was initiated because the alarm lights on the affected touchscreen displays may fail to illuminate upon installation. This potential failure could affect the visual alarm functionality of the bedside monitor.

The affected units were distributed worldwide, including in the United States (nationwide, including Alaska, California, Florida, Illinois, Michigan, South Carolina, and Texas) and in Canada, Chile, France, Libya, Panama, Qatar, Saudi Arabia, Switzerland, and the United Kingdom. Users should contact Spacelabs Healthcare for further instructions regarding the recall and replacement of the affected units.

The recalled product

Product: 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 Spa
Manufacturer: Spacelabs Healthcare, Llc
Category: Medical Device — Patient Monitoring
Hazard: alarm-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial Number for U.S. Cosignees: PRO-12240004
PRO-12240015
PRO-12240017
PRO-12240018
PRO-12240022
PRO-12240026
PRO-12240028
PRO-12240030
PRO-12240031
PRO-12240032
PRO-12240033
PRO-12240034
PRO-12240036
PRO-12240037
PRO-12240038
PRO-12240040
PRO-12240041
PRO-12240058
PRO-12240059
PRO-12240062

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · Spacelabs Healthcare, Llc

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