Agfa N.V.: DX-D 100 Mobile X-ray Systems Recalled Due to Potential Mechanical Failure

What You Should Do

1. Identify if your facility is using an Agfa DX-D 100 Digital Radiography mobile X-ray system by checking the model and serial numbers on the device's identification plate.
2. Confirm your unit is affected by matching it against the following serial numbers: A5411001002, A5411001003, A5411001005, A5411001033 through A5411001039, A5411001064 through A5411001069, A5411001073, A5411001080, A5411001081, A5411001087, A5411001089, A5411001090, A5411001097, A5411001098, A5411001099, A5411001105, A5411001110, A5411001112, A5411001149, A5411001151, A5411001152, A5411001162 through A5411001165, A5411001174 through A5411001177, A5411001201, A5411002007, A5411002023 through A5411002025, A5411002029 through A5411002033, A5411002047 through A5411002049, A5411002051 through A5411002054, A5411002058 through A5411002061, A5411002063 through A5411002065, A5411002070 through A5411002074, A5411002076, A5411002078, A5411002082 through A5411002085, A5411002128 through A5411002131, A5411002143 through A5411002147, A5411002152, A5411002160 through A5411002162, A5411002171 through A5411002173, A5411002182 through A5411002188, A5411002199 through A5411002206, A5411002208, A5411002212, A5411002234, A5411002236, A5411002247, A5411002249, A5411002257, A5411002263, A5411002265, A5411002269, A5411003022 through A5411003024, A5411003027, A5411003028, A5411003031, A5411003032, A5411003038 through A5411003040, A5411003042, A5411003044, A5411003045, A5411003047 through A5411003049, A5411003051, A5411003054 through A5411003063, A5411003065, A5411003068, A5411003070 through A5411003074, A5411003080 through A5411003086, A5411003090 through A5411003094, A5411003096, A5411003097, A5411003099 through A5411003110, A5411003132 through A5411003134, A5411003145, A5411003146, A5411003149 through A5411003157, A5411003162 through A5411003169, A5411003188, A5411003189, A5411003192, A5411003195 through A5411003198, A5411003200 through A5411003202, A5411003237, A5411003243 through A5411003248, A5411003254 through A5411003258, A5411003263 through A5411003272, A5411003274 through A5411003278, A5411003282 through A5411003284, A5411003287 through A5411003292, A5411003305, A5411003314, A5411003315, and A5411003318.
3. Check your facility's email for a notification from Agfa N.V. regarding this voluntary recall initiation.
4. Contact Agfa N.V. or your medical equipment service provider immediately to arrange for an inspection and repair of the mobile column and safety system.
5. Contact your healthcare provider or the manufacturer for further instructions regarding the safety of continued use of the equipment and any potential refund or replacement options.
6. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products