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All Recalls

Every Spacelabs Healthcare, Llc Recall

Sorted by most recent. Click any recall for full details.

7 recalls
High RiskFDA
Spacelabs Healthcare, Llc
Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ...
Medical Devices·36 affected·Feb 14, 2014
High RiskFDA
Spacelabs Healthcare, Llc
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube...
Medical Devices·54 affected·Oct 17, 2013
High RiskFDA
Spacelabs Healthcare, Llc
Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The S...
Medical Devices·27 affected·Dec 5, 2012
High RiskFDA
Spacelabs Healthcare, Llc
The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and ...
Medical Devices·169 affected·Oct 5, 2012
High RiskFDA
Spacelabs Healthcare, Llc
Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the...
Medical Devices·527 affected·Aug 27, 2012
High RiskFDA
Spacelabs Healthcare, Llc
Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection o...
Medical Devices·21 affected·Jun 12, 2012
High RiskFDA
Spacelabs Healthcare, Llc
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0...
Medical Devices·114 affected·May 11, 2012