No packaging. The device is a computed tomography recall
No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the…
Why was No packaging. The device is a computed tomography recalled?
When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
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 2.2.1 and 2.2.2
- Product
- No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 61
- Distribution
- Worldwide Distribution - US including MO, TX, MD, AR, VA, KY, RI, NJ, MA, NY, LA, PA, VT, SC, CA, OH, FL, MN, MI and Internationally to Netherlands, Canada, Finland, Austria, France, Malaysia, Denmark, Norway, UK, Australia, Belgium, New Zealand.
- Recall date
- October 1, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)