ddR Formula B X-ray System recall
ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Why was ddR Formula B X-ray System recalled?
Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
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
- Product
- ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
- Recalling firm
- Swissray Medical
- Quantity
- 27 devices in US
- Distribution
- Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa.
- Recall date
- September 26, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)