Z-1705-2014Class II

Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The...

Name: Z-1705-2014 Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The...
Creator: Spacelabs Healthcare Inc
Published: 2014-05-08
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-05-08 / Terminated / root cause: software

FDA source

Spacelabs Healthcare Inc began a recall of Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management... on 2014-05-08. FDA classified it as Class II and gives the reason as "A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1705-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-08
Posted: 2014-06-03
Terminated: 2014-06-03
Recalling firm: GE Healthcare
Product: 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 code: DSI Detector And Alarm, Arrhythmia
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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Spacelabs Healthcare identified a software anomaly in the Ultraview SL" Command Module, Model 91496. During an internal audit, Spacelabs identified a reportable recall that was not reported. We have a product called the Spacelabs Medical Ultraview SL" Command Module, Model 91496. A software error was discovered at a customer site which was not a safety issue, but in the interest of customer service it was decided to downgrade all their modules with an older software version.
Quantity in commerce: 64 devices
Distribution: US Distribution to GA.
Product codes and lots: All devices of Model: 91496.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1705-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1705-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-03

Product code DSI

K103142Class IISpacelabs Multi-Parameter ModuleSpacelabs Healthcare, Inc. / cleared 2011-03-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)