Reported Sep 26, 2012 · Terminated
Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are…
Spacelabs Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spacelabs Healthcare, Llc · 5150 220th Ave Se · Issaquah, WA · 98029-6834
Is this the product you have?
- 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.
- Lot codes and dates
526 of 526 codes
Domestic - 1493-0002751493-0002761493-0002771493-0024691493-0026161493-0033581493-0033591493-0036671493-0036681493-0036691493-0036701493-0036711493-0036721493-0036731493-0036741493-0036751493-0036761493-0036771493-0036781493-0036791493-0036801493-0036811493-0036821493-0036831493-0036841493-0036851493-0036861493-0036871493-0036881493-0036931493-0036941493-0036951493-0036961493-0036971493-0038791493-0038801493-0038811493-0038821493-0038831493-0038841493-0038851493-0038861493-0038871493-0038881493-0038891493-0038901493-0038911493-0038921493-0038931493-0038941493-0038951493-0038961493-0038971493-0038981493-0038991493-0039001493-0039011493-0039021493-0039031493-003904
- Amount recalled
- 527 units total; 350 US and 177 International
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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