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/ 050
    • A5411/ 0300 and A5411/ 0400
Lot codes and dates
  • UDI5414904272725YG
  • US Serial NumbersSerial Number

    247 of 247 codes

    • A5411001002
    • A5411001003
    • A5411001005
    • A5411001033
    • A5411001034
    • A5411001035
    • A5411001036
    • A5411001037
    • A5411001038
    • A5411001039
    • A5411001064
    • A5411001065
    • A5411001066
    • A5411001067
    • A5411001068
    • A5411001069
    • A5411001073
    • A5411001080
    • A5411001081
    • A5411001087
    • A5411001089
    • A5411001090
    • A5411001097
    • A5411001098
    • A5411001099
    • A5411001105
    • A5411001110
    • A5411001112
    • A5411001149
    • A5411001151
    • A5411001152
    • A5411001162
    • A5411001163
    • A5411001164
    • A5411001165
    • A5411001174
    • A5411001175
    • A5411001176
    • A5411001177
    • A5411001201
    • A5411002007
    • A5411002023
    • A5411002024
    • A5411002025
    • A5411002029
    • A5411002030
    • A5411002031
    • A5411002032
    • A5411002033
    • A5411002047
    • A5411002048
    • A5411002049
    • A5411002051
    • A5411002052
    • A5411002053
    • A5411002054
    • A5411002058
    • A5411002059
    • A5411002060
    • A5411002061
  • Canada Serial NumbersSerial Number
    • A5411001006
    • A5411002022
    • A5411002026
    • A5411002057
    • A5411002069
    • A5411002075
    • A5411002077
    • A5411002086
    • A5411003014
    • A5411003029
    • A5411003030
    • A5411003037
    • A5411003050
    • A5411003066
    • A5411003087
    • A5411003124
    • A5411003125
    • A5411003135
    • A5411003136
    • A5411003137
    • A5411003138
    • A5411003139
    • A5411003140
    • A5411003141
    • A5411003147
    • A5411003148
    • A5411003170
    • A5411003171
    • A5411003181
    • A5411003184
    • A5411003190
    • A5411003285
    • A5411003286
  • Foreign Serial NumbersSerial Number

    261 of 261 codes

    • A5411000451
    • A5411001000
    • A5411001001
    • A5411001004
    • A5411001007
    • A5411001012
    • A5411001018
    • A5411001031
    • A5411001032
    • A5411001041
    • A5411001061
    • A5411001062
    • A5411001063
    • A5411001074
    • A5411001075
    • A5411001076
    • A5411001106
    • A5411001107
    • A5411001126
    • A5411001127
    • A5411001131
    • A5411001132
    • A5411001134
    • A5411001137
    • A5411001157
    • A5411001158
    • A5411001159
    • A5411001160
    • A5411001161
    • A5411001193
    • A5411001194
    • A5411001195
    • A5411001203
    • A5411001207
    • A5411001210
    • A5411001211
    • A5411001212
    • A5411001213
    • A5411002000
    • A5411002001
    • A5411002002
    • A5411002003
    • A5411002004
    • A5411002005
    • A5411002006
    • A5411002008
    • A5411002009
    • A5411002010
    • A5411002012
    • A5411002013
    • A5411002015
    • A5411002016
    • A5411002020
    • A5411002021
    • A5411002027
    • A5411002028
    • A5411002035
    • A5411002036
    • A5411002038
    • A5411002039
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.