FDA Class II Recall: Ultraview SL Command Module Monitoring Alarms May Fail
Spacelabs Healthcare is recalling 1,088 Ultraview SL Command Module units due to a software defect. The devices may fail to display alarms or waveforms when parameter processing is suspended, potentially causing clinicians to miss critical patient events.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall without any reported illnesses, injuries, or deaths. The hazard is theoretical—clinicians could miss critical patient events due to monitoring display failures—but no actual patient harm has been documented. Per the rubric, a risk-of-harm product with no reported injuries scores at most High (3).
Plain-English summary
Spacelabs Healthcare, Inc. is recalling 1,088 units of the Ultraview SL (UVSL) Command Module, Model 91496, a patient monitoring device used in healthcare settings. The recall affects units with software version 2.03.06 and earlier, or software version 2.04 and later, distributed nationwide across the United States.
The devices contain a software defect that affects the display of patient monitoring data when parameter processing is suspended. Depending on the software version, either waveforms display without triggering alarms, or neither waveforms nor alarms are displayed at all. In either scenario, clinicians may not receive the alerts necessary to detect critical patient events.
Healthcare facilities currently using affected units should verify their device software versions and contact Spacelabs Healthcare regarding available software updates or remediation options. The manufacturer recommends reviewing the device status and manually monitoring patients when parameter processing suspends. No patient injuries or illnesses have been reported to date related to this defect.
The recalled product
- Product
- Ultraview SL (UVSL) Command Module, Model 91496
- Manufacturer
- Spacelabs Healthcare, Inc.
- Hazard
- alarm-failure
- waveform-failure
- monitoring-gap
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software version 2.03.06 and earlier and software version 2.04 and later.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
- SevereSurgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk
FDA (Devices) · 2026-07-01
- SevereVOCSN+Pro Respiratory System Backup Battery Alarm Failure Recall
FDA (Devices) · 2026-07-01