Phoenix mKDR recall
Phoenix mKDR, digital mobile diagnostic x-ray system
Why was Phoenix mKDR recalled?
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI/DI 08436046003002, Serial Numbers: PH00092, PH00093, PH00094, PH00095, PH00097, PH00098, PH00099, PH00100, PH00110, PH00111, PH00112, PH00113, PH00114, PH00115, PH00116, PH00117, PH00118, PH00135, PH00136, PH00137, PH00138, PH00139, PH00140, PH00141, PH00142, PH00143, PH00144, PH00161, PH00162, PH00163, PH00164, PH00165, PH00166, PH00167, PH00168, PH00169, PH00176, PH00177, PH00178, PH00179, PH00180, PH00181, PH00185, PH00186, PH00187, PH00188, PH00189, PH00190, PH00191, PH00192, PH00010, PH00090, PH00091
- Product
- Phoenix mKDR, digital mobile diagnostic x-ray system
- Recalling firm
- SEDECAL SA
- Quantity
- 53 units
- Distribution
- US, Argentina, Panama
- Recall date
- March 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)