Agfa-Gevaert Recalls DX-D 600 Direct Radiography Systems Due to Movement Defect
Agfa-Gevaert is recalling 10 DX-D 600 Direct Radiography Systems because the Overhead Tube Crane may continue moving after the control button is released.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a mechanical failure in a medical device that could lead to unintended movement and potential injury, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Agfa-Gevaert, N.V. is recalling 10 units of the DX-D 600 Direct Radiography System. This ceiling-mounted X-ray imaging system is used in hospitals, clinics, and medical practices to create and view static radiographic images of various body parts.
The recall was initiated after a software upgrade to the Overhead Tube Crane resulted in isolated cases where the crane movement did not stop when the movement button was released. Instead of halting, the Tube Head Crane continued to move to the intended position.
The affected units were distributed in the United States in the states of Indiana, Kansas, Massachusetts, South Carolina, and Virginia. The specific serial numbers for the recalled units are A5430000015, A5430000020, A5430000030, A5430000042, A5430000052, A5430000061, A5430000066, A5430000067, A5430000079, and A5430000081. Healthcare facilities should contact the manufacturer for instructions on how to address this issue.
The recalled product
- Product
- DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray…
- Manufacturer
- Agfa-Gevaert, N.V.
- Hazard
- Affected units
- 10
Distribution
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