Allura Xper Product Usage: Vascular recall
Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive…
Why was Allura Xper Product Usage: Vascular recalled?
The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
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?
Allura 8.1.25 Allura 8.1.25.1 Allura 8.1.25.5 Allura 8.2.25 Allura 8.2.25.5 Allura 8.2.27
- Product
- Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive…
- Recalling firm
- Philips Healthcare
- Quantity
- 459 affected systems
- Distribution
- US Nationwide Distribution
- Recall date
- August 1, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)