Brilliance CT recall: Software Issue
Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide…
Why was Brilliance CT recalled?
Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.
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?
Model # 728243 Software Version 2.0
- Product
- Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 54 units
- Distribution
- Worldwide distribution, including US states of CA and NV.
- Recall date
- December 16, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)