Spacelabs Medical Xprezzon Bedside Monitor, Model 91393… recallZ-2019-2012 · Spacelabs Healthcare, Llc · initiated Jun 12, 2012

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

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 emailed to all international subsidiaries and distributors of record. Customers with questions can contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support. For questions regarding this recall call 800-522-7025, ext 2.

Recall details

Recall number

Z-2019-2012

Recall class

Class II

Status

Terminated

Initiated by the company

Jun 12, 2012

Posted by the FDA

Jul 16, 2012

Recalling firm

Spacelabs Healthcare, Llc

Quantity

21 units

Product code

MHX

FDA submissions

K112962

Distribution

Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama.

Product description

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 displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Spacelabs Healthcare Xprezzon Bedside Monitor may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitor allows network based applications to open windows and display information the Xprezzon and other networked monitors. The Spacelabs Healthcare Xprezzon Bedside Monitor is designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Xprezzon Bedside Monitors is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

Other devices under the same FDA submission

2 devices cleared under K112962 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Xprezzon Xprezzon Monitor

  Spacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  3 recalls3 reports
• Xprezzon Xprezzon Monitor

  Spacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  2 reports