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Spacelabs Healthcare, Llc recalls Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are
Recalled September 26, 2012 · FDA recall Z-2382-2012 · Spacelabs Healthcare
Hazard
There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing. · FDA Class II
Units
527 units total; 350 US and 177 International
Sold at
Worldwide Distribution.
Description
There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.
Product
Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.
Manufacturer(s)
Spacelabs Healthcare, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →