04

Mar

2015

Cl II Spacelabs Healthcare qube Compact Monitor

0

Company:Spacelabs Healthcare Inc.
Date of Enforcement Report: 3/4/2015
Class lI:

PRODUCT

Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
Recall Number Z-1145-2015

REASON
Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has received multiple reports of qube monitors failing to boot up or returning to factory default configuration settings following power on or reset..

RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare Inc., Snoqualmie, WA on 1/28/2015 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
ttotal 2955 units (2117 units in US and 838 units outside US)

DISTRIBUTION
Worldwide

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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