Poly G Integris H5000 recall
Poly G Integris H5000, System code 72246
Why was Poly G Integris H5000 recalled?
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
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?
System equipment number 519212
- Product
- Poly G Integris H5000, System code 72246
- Recalling firm
- Philips North America, LLC
- Quantity
- 1
- Distribution
- Nationwide domestic distribution. Foreign distribution worldwide.
- Recall date
- March 25, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)