Spacelabs Medical Ultraview SL Command Module, Model 91496 recallZ-0776-2012 · Spacelabs Healthcare, Llc · initiated Jul 13, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spacelabs Healthcare, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
One Spacelabs Medical Ultraview SL Command Module, Model 91496, was removed from customer due to software error.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0776-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 13, 2011
- Posted by the FDA
- Jan 17, 2012
- Recalling firm
- Spacelabs Healthcare, Llc
- Quantity
- one unit
- Product code
- DSI
- FDA submissions
- K103142
- Distribution
- One device distributed in Troy, MI.
Product description
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.
Code information (models, lots, serial numbers)
Serial number: 1496-029792
Other devices under the same FDA submission
2 devices cleared under K103142 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Ultraview SL Ultraview SL®Spacelabs Healthcare (Washington), Inc · SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE2 recalls2 reports
- Ultraview SL UV SL Command ModuleSpacelabs Healthcare (Washington), Inc · DETECTOR AND ALARM, ARRHYTHMIA1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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