Spacelabs Medical Ultraview SL Command Module, Model 91496 recallZ-1705-2014 · Spacelabs Healthcare Inc · initiated May 8, 2014
Class II Terminated All recalls posted in June 2014
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 Inc 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
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
FDA root cause category: Software Manufacturing/Software Deployment
What the company is doing
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.
Recall details
- Recall number
- Z-1705-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 8, 2014
- Posted by the FDA
- Jun 3, 2014
- Recalling firm
- Spacelabs Healthcare Inc
- Quantity
- 64 devices
- Product code
- DSI
- FDA submissions
- K103142
- Distribution
- US Distribution to GA.
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.
Code information (models, lots, serial numbers)
All devices of Model: 91496.
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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