The Recall Desk
ModerateFDA (Devices)·Z-1705-2014·Announced 2014-06-11

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.

What this means for you

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 environment.
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: