CuattroDR System Software recall
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Why was CuattroDR System Software recalled?
There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
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?
Product Version: 4.4.128
- Product
- CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
- Recalling firm
- Cuattro LLC
- Quantity
- 9 units
- Distribution
- US: NJ, MI, SC, NC, MI, AR, OUS: None
- Recall date
- May 20, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)