Intel-GE Care Innovations Recalls QuietCare Facility Servers for Software Defect
Intel-GE Care Innovations is recalling 19 QuietCare Facility Servers due to a software defect that may prevent Wander Alerts from being generated.
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 3/5 (High).
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: The recall involves a medical device with a software defect that could prevent safety alerts (Wander Alerts) from being generated. This represents a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Intel-GE Care Innovations LLC is recalling 19 units of the QuietCare-Networked product, Facility Server, model QC101601. The QuietCare system is intended to detect and analyze residents' movements. The recall covers all units of this model that were distributed nationwide.
The recall was initiated after the company detected a software anomaly during an engineering investigation. The investigation was triggered by a failure to generate a Wander Alert. The defect was found in the implementation of the Wander and Night Motion Activities of Daily Living (ADLs) features.
Facilities using the affected QuietCare Facility Servers should contact Intel-GE Care Innovations LLC for instructions on how to address the software defect.
The recalled product
- Product
- QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
- Manufacturer
- Intel-GE Care Innovations LLC
- Affected units
- 19
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 units of this model.
Distribution
Distributed nationwide across the United States.
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