Recall Z-0196-2013— Spacelabs Healthcare, Llc

Name: FDA recall Z-0196-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-05

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare, Llc, initiated 2012-10-05, terminated 2013-03-25. It names one FDA 510(k) clearance: K112962. 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 Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules.. Reason: Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation..

Recalling firm: Spacelabs Healthcare, Llc
Classification: Class II
Status: Terminated
Initiated: 2012-10-05
Terminated: 2013-03-25
Firm location: Issaquah, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K112962 — SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)Spacelabs Medical, Inc.·cleared 2011-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation.

Data sourced from openFDA. This site is unofficial and independent of the FDA.