Health Products

CareIntellect Perinatal

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: CareIntellect Perinatal
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
CareIntellect PerinatalVersion 2.3.1K2504AA

Issue

GE Healthcare has become aware of an issue in CareIntellect Perinatal (CIP) that may result in loss of monitoring information and clearance of active patient monitoring alarms. When this issue occurs due to an interruption in system connectivity, monitoring data will be unavailable for up to approximately 20 seconds and currently active visual and audible alarm indicators will no longer be displayed or announced at the CIP user interface. Following resolution of system connectivity, alarm triggers will restart based on the configured thresholds. This issue could delay recognition of a maternal or fetal condition requiring clinical assessment or intervention.

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