Spacelabs Ultraview SL Command Module Recalled for Software Anomaly
Spacelabs Healthcare is recalling 64 Ultraview SL Command Modules because a software anomaly causes false positive temperature alarms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves nuisance false positive alarms rather than direct physical injury or death, fitting the criteria for moderate severity involving low-risk issues or voluntary precautionary measures.
Plain-English summary
Spacelabs Healthcare Inc is recalling 64 units of the Spacelabs Medical Ultraview SL Command Module, Model 91496. This device is an arrhythmia detector and alarm used with the Patient Care Management System (PCMS) to acquire, monitor, and process clinical parameters from patients in clinical environments.
The recall is due to a software anomaly that causes temperature alarm limits to change to values that are not physiologically possible. This malfunction results in nuisance false positive alarms. The devices were distributed in the United States to Georgia.
No specific instructions for consumers are provided in the source text, but the recall is managed by Spacelabs Healthcare Inc.
The recalled product
- 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…
- Manufacturer
- Spacelabs Healthcare Inc
- Affected units
- 64
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)
- All devices of Model: 91496.
Distribution
Distributed in 1 state:
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