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  5. Chest Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping Compressions
  1. Medical Device Recalls

Chest Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping Compressions

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

RMU-2000 Chest Compression Module
  • RMU-2000 Chest Compression Module
    • Product Name: RMU-2000 ARM XR Chest Compression Device
    • Unique Device Identifier (UDI)/: UDI-DI: 00815098020812, 10815098020819 
    • Serial Numbers: See full list.

What to Do

Do not use affected Defibtech RMU-2000 ARM XR Chest Compression Devices (identified by serial numbers).

On July 12, 2024, Defibtech, LLC, sent all affected customers an Urgent Medical Device Safety Removal letter recommending the following actions: 

  • Identify and quarantine affected units.
  • If devices were transferred or distributed further, please ensure the recipients are aware of this notice or provide Defibtech with contact information.

Customers will be contacted by Defibtech to arrange for product return and devices will be refunded, repaired, or replaced at no cost.

Reason for Recall

Defibtech, LLC, is recalling RMU-2000 ARM XR Chest Compression Devices due to a problem with the device’s motor that may cause it to stop compressions.

The use of affected product may cause serious adverse health consequences, including patient injuries, delay of therapy and death due to a period of time without compressions to circulate oxygen throughout the body.

There has been one reported injury and one report of death. 

Device Use

The RMU-2000 ARM XR Chest Compression Device is used to provide chest compressions on adults whose hearts suddenly stop and are not circulating blood throughout the body.

Contact Information

Customers in the U.S. with questions about this recall should contact Defibtech Customer Support: 1-877-453-4507, 7:30AM - 6PM Eastern.

Full List of Affected Devices

  • Unique Device Identifier (UDI)/Model: UDI-DI: 00815098020812, 10815098020819
  • Serial Numbers:

502000249
502000248
502000205
502000216
502000217
502000237
502000987
502000235
502000246
502000946
502000236
502000948
502000247
502000953
502000262
502000952
502001047
502000968
502000991
502001012
502000930
502001048
502001013
502000252
502000967
502000977
502000253
502000926
502000229
502000915
502000982
502000285
502000219
502000956
502000275
502000232
502000078
502000223
502000932
502000922
502000943
502000068

502000067
502000272
502000211
502000240
502001067
502000933
502000228
502001014
502000995
502001057
502001056
502001015
502000961
502000970
502000949
502000951
502000269
502000221
502000215
502000271
502000257
502000959
502000910
502000261
502000916
502000259
502000256
502000204
502000227
502000074
502000225
502000220
502000958
502000941
502000294
502000966
502000937
502001050
502000206
502001008
502000279
502000254

502001052
502000947
502001011
502001001
502001058
502000904
502000233
502000203
502000291
502000210
502000983
502000202
502001003
502000962
502000921
502000918
502000928
502000241
502000913
502000280
502000234
502000907
502000064
502000231
502000938
502000927
502000238
502000939
502000963
502000296
502001006
502000263
502000996
502000950
502000243
502001053
502000978
502001016
502000964
502001051
502000909
502000251

502000997
502000288
502000283
502000299
502000293
502000278
502000984
502000209
502000914
502000242
502000287
502000218
502000297
502000267
502000908
502000072
502000222
502000934
502000944
502000998
502000284
502000929
502000226
502001055
502001054
502000265
502000986
502000954
502001007
502001010
502001068
502000277
502001009
502000912
502001004
502000957
502000239
502000975
502000917
502000286
502000282
502000911

502000925
502000244
502000965
502000268
502000971
502000994
502000270
502000980
502000224
502000245
502000945
502000942
502000250
502000212
502000903
502000260
502000935
502001073
502000969
502001002
502000999
502000993
502001017
502001049
502000255
502000274
502000905
502000298
502000989
502000931
502000901
502000923
502000258
502000213
502000292
502000900
502000207
502000266
502000273

Additional FDA Resources

Additional Company Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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