Recall Z-2019-2012 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Llc
Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displ
| Date | Jul 16, 2012 (initiated Jun 12, 2012) |
| Status | Terminated |
| Reason | There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. The parameters return after power cycling the monitor. |
| Root cause | Software design |
| Action | Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated June 29 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to advise their staff of the potential failure of the XPREZZON Bedside Monitor. Spacelabs will contact customers to schedule a convenient time for their hospital to upgrade their affected monitors, at no cost. On July 6 2012, a customer letter (translated as necessary) URGENT - MEDICAL DEVICE CORRECTION Spacelabs Healthcare XPREZZON Bedside Monitor will be e |
| Quantity | 21 units |
| Distribution | Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112962 | SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) Spacelabs Medical, Inc., Nov 2, 2011 |