Qube spacelabs6/19/2023 ![]() Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.ĥ10(K)s with Product Code = MHX and Original Applicant = SPACELABS MEDICAL, INC. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. ![]() This letter described the affected system, problem, actions to be taken by users and corrective actions conducted by Spacelabs.įor additional information or technical assistance, please contact:ĭistributed in North Carolina, Texas, and Wyomingġ A record in this database is created when a firm initiates a correction or removal action. The firm sent the Urgent Medical Device Correction- Spacelabs Healthcare Inc.-qube Compact Monitor, Model 91390, Power Input PCBA Failure letter, dated, via priority service mail to US consignees. This letter described the affected system, problem, actions to be taken by users and corrective actions conducted by Spacelabs. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013). The firm sent the Urgent Medical Device Correction- Spacelabs Healthcare Inc.-qube Compact Monitor, Model 91390, Power Input PCBA Failure letter, dated, via priority service mail to US consignees. In addition, there is the potential for the qube Compact Monitor to fail to turn on. The input power can fail even though the power source at the wall has not been interrupted. The monitor is 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. Spacelabs qube Compact Monitor, Model 91390. ![]() Monitor, physiological, patient (with arrhythmia detection or alarms) - Product Code MHX Class 2 Device Recall Spacelabs qube Compact Monitor, Model 91390 ![]()
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