Reported Oct 3, 2018 · Terminated
DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in…
Agfa N.V.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Agfa N.V. · Septestraat 27 · Mortsel · N/A
Is this the product you have?
- DX-D 600 Product UsageThe 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 radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients
- Lot codes and dates
- Serial Nos
108 of 108 codes
A5430000015A5430000020A5430000030A5430000042A5430000045A5430000052A5430000053A5430000054A5430000057A5430000058A5430000060A5430000061A5430000063A5430000066A5430000067A5430000068A5430000074A5430000079A5430000081A5430000085A5430000089A5430000095A5430000096A5430000100A5430000105A5430000106A5430000107A5430000108A5430000119A5430000121A5430000124A5430000125A5430000130A5430000131A5430000132A5430000133A5430000137A5430000143A5430000144A5430000149A5430000156A5430000162A5430000165A5430000166A5430000172A5430000176A5430000177A5430000183A5430000184A5430000199A5430000206A5430000207A5430000215A5430000218A5430000222A5430000224A5430000225A5430000226A5430000228A5430000229
- Serial Nos
- Amount recalled
- 108
Where it was sold
Why it was recalled
A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others.
This product could cause temporary or reversible health problems — stop using it.
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