Z-0776-2012

Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended...

Name: Z-0776-2012 Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended...
Creator: Spacelabs Healthcare, Llc
Published: 2011-07-13
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-07-13 / Terminated / root cause: software

FDA source

Spacelabs Healthcare, Llc began a recall of Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System... on 2011-07-13. The reason FDA records is "One Spacelabs Medical Ultraview SL Command Module, Model 91496, was removed from customer due to software error". 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-0776-2012
Status: Terminated
Initiated: 2011-07-13
Posted: 2012-01-17
Terminated: 2012-01-20
Recalling firm: GE Healthcare
Product: Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: One Spacelabs Medical Ultraview SL Command Module, Model 91496, was removed from customer due to software error.
Root cause tag: software
FDA root cause: Software design
Action: Spacelabs removed one affected unit of Medical Ultraview SL Command Module from a hospital in Troy, MI. during a site visit on July 13, 2011. This recall pertains to one single unit at one location. Contact Spacelabs at 425-657-7200 for questions regarding this recall.
Quantity in commerce: one unit
Distribution: One device distributed in Troy, MI.
Product codes and lots: Serial number: 1496-029792

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)