DR 800 Digital Radiography X-ray Table Front Lever Chain Potential Failure
Agfa is recalling 141 DR 800 Digital Radiography X-ray systems for potential failure of the table's front lever chain.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving potential failure of a mechanical component on an X-ray table. The failure could injure patients or operators. Per the severity rubric, Class II recalls with risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Agfa N.V. is recalling 141 units of the DR 800 Digital Radiography X-ray System due to potential failure of the front lever chain on the table.
The affected devices were distributed to medical facilities in multiple U.S. states including California, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Missouri, New Jersey, North Carolina, Ohio, Oklahoma, South Carolina, Virginia, West Virginia, and Wisconsin. International distribution included Australia, Belgium, Botswana, Canada, Colombia, Czech Republic, Germany, Spain, France, United Kingdom, Greece, Israel, India, Italy, Kazakhstan, Mexico, Poland, Serbia, Uzbekistan, and South Africa.
The FDA has classified this recall as a Class II medical device recall due to the potential hazard associated with the table component.
The recalled product
- Product
- DR 800. Digital Radiography X-ray System.
- Manufacturer
- Agfa N.V.
- Hazard
- mechanical-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Type No. 6010/200
- UDI-DI: 05414904251805
- Device Serial No. 925
- 945
- 948
- 949
- 990
- 1003
- 1022
- 1116
- 1136
- 1161
- 1229
- 1239
- 1401
- 1404
- 1453
- 1460
- 1489
- 1506
Distribution
Distributed nationwide across the United States.
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