FDAFDA · Food and drugs·Recall number Z-1705-2014
Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment.
Published June 11, 2014 · Recall initiated: May 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Spacelabs Healthcare Inc
- Distributor
- US Distribution to GA.
- Lot
- All devices of Model: 91496.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.