ClearanceBrief
Recall Z-1705-2012 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Spacelabs Healthcare, Llc

Product is the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393. The 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 displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature

DateJun 5, 2012 (initiated May 22, 2012)
StatusTerminated
ReasonThe screw used to connect the external power supply to the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, may damage an internal capacitor. The damage may result in an inability of the monitor to power on, power off, or involuntarily shut down.
Root causeDevice Design
ActionThe firm, Spacelabs Healthcare, sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated May 22, 2012 via return receipt requested, to US customers. On May 29, 2012 a translated customer letter was emailed to all international subsidiaries and distributors of record. The letter describes the product, problem and actions to be taken. The customers were instructed to notify staff of the potential failure and to only tighten the power supply screw with their fingers. In addition, the firm will schedule a time to upgrade the monitors at the customers site. If you have any questions about this c
Quantity1898 monitors (Domestic: 1188) (International: 710)
DistributionWorldwide distribution: USA (nationwide) and countries including: Australia, Canada, Chile, China, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, India, Italy, Kuwait, Malaysia, Netherlands, Panama, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Switzerland,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K112962SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
Spacelabs Medical, Inc., Nov 2, 2011