eCare Coordinator Product Usage: is software intended recall: Software Issue
eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information…
Why was eCare Coordinator Product Usage: is software intended recalled?
eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. A software defect was discovered in the Philips eCareCoordinator (eCC) Clinical User Interface that can at times cause missing or redundant data to be saved without notification to the user.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
453564506091 eCareCoordinator
- Product
- eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information…
- Recalling firm
- Philips Visicu
- Quantity
- 26
- Distribution
- Worldwide Distribution-US Nationwide
- Recall date
- April 12, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)