Reported Apr 10, 2024 · Ongoing
Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console,…
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?
- Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients
- Models
5411/ 050A5411/ 0300 and A5411/ 0400
- Lot codes and dates
- UDI5414904272725YG
- US Serial NumbersSerial Number
247 of 247 codes
A5411001002A5411001003A5411001005A5411001033A5411001034A5411001035A5411001036A5411001037A5411001038A5411001039A5411001064A5411001065A5411001066A5411001067A5411001068A5411001069A5411001073A5411001080A5411001081A5411001087A5411001089A5411001090A5411001097A5411001098A5411001099A5411001105A5411001110A5411001112A5411001149A5411001151A5411001152A5411001162A5411001163A5411001164A5411001165A5411001174A5411001175A5411001176A5411001177A5411001201A5411002007A5411002023A5411002024A5411002025A5411002029A5411002030A5411002031A5411002032A5411002033A5411002047A5411002048A5411002049A5411002051A5411002052A5411002053A5411002054A5411002058A5411002059A5411002060A5411002061
- Canada Serial NumbersSerial Number
A5411001006A5411002022A5411002026A5411002057A5411002069A5411002075A5411002077A5411002086A5411003014A5411003029A5411003030A5411003037A5411003050A5411003066A5411003087A5411003124A5411003125A5411003135A5411003136A5411003137A5411003138A5411003139A5411003140A5411003141A5411003147A5411003148A5411003170A5411003171A5411003181A5411003184A5411003190A5411003285A5411003286
- Foreign Serial NumbersSerial Number
261 of 261 codes
A5411000451A5411001000A5411001001A5411001004A5411001007A5411001012A5411001018A5411001031A5411001032A5411001041A5411001061A5411001062A5411001063A5411001074A5411001075A5411001076A5411001106A5411001107A5411001126A5411001127A5411001131A5411001132A5411001134A5411001137A5411001157A5411001158A5411001159A5411001160A5411001161A5411001193A5411001194A5411001195A5411001203A5411001207A5411001210A5411001211A5411001212A5411001213A5411002000A5411002001A5411002002A5411002003A5411002004A5411002005A5411002006A5411002008A5411002009A5411002010A5411002012A5411002013A5411002015A5411002016A5411002020A5411002021A5411002027A5411002028A5411002035A5411002036A5411002038A5411002039
- Amount recalled
- 541 units
Where it was sold
- Nationwide
Why it was recalled
Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury
This product could cause temporary or reversible health problems — stop using it.
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