Spacelabs Healthcare Inc: Medical Device Recall in 2014 - (Recall #: Z-1705-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 8, 2014

Date Posted: June 11, 2014

Recall Number: Z-1705-2014

Event ID: 68357

Reason for Recall:

A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.

Status: Terminated

Product Quantity: 64 devices

Code Information:

All devices of Model: 91496.

Distribution Pattern:

US Distribution to GA.

Voluntary or Mandated:

Voluntary: Firm initiated