ddR Formula B X-ray System recall
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
Why was ddR Formula B X-ray System recalled?
Possible injury due to movement of the arm, calibration loss and communication loss.
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?
Serial Numbers within U.S.A commerce - 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007, 1402008, 1402009, 1402011, 1402012, 1402015, 1502001, 1502002, 1502004, 1502005, 1502006, 1502007, 1602001, 1602002, 1602003, 1602005, 1602006, 1602007 & 1602008 Serial Numbers Outside of U.S.A commerce - 1402005, 1402017, 1502009, 1502010, 1502011, 1302004, 1302006, 1302007, 1302008, 1302010, 1402003, 1402004, 1402010, 1402013, 1402014, 1402016, 1502008, 1602004, 1702001, 1702002, 1702003 & 1702004
- Product
- ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
- Recalling firm
- Swissray Medical
- Quantity
- 26 units
- Distribution
- US Nationwide
- Recall date
- October 3, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)