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U.S. Department of Health and Human Services

Class 1 Device Recall RMU2000

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 Class 1 Device Recall RMU2000see related information
Date Initiated by FirmJuly 12, 2024
Date PostedAugust 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2543-2024
Recall Event ID 94960
510(K)NumberK211289 
Product Classification Compressor, cardiac, external - Product Code DRM
ProductRMU-2000 Automated Chest Compression Device
Code Information UDI-DI: 00815098020812, 10815098020819 Serial numbers 502001000 502000281 502000979 502000960 502000985 502000988 502000264 502000201 502000973 502000249 502000248 502000205 502000216 502000217 502000275 502000204 502000234 502000267 502000270 502000237 502000232 502000227 502000907 502000908 502000980 502000987 502000078 502000074 502000064 502000072 502000224 502000235 502000223 502000225 502000231 502000222 502000245 502000246 502000932 502000220 502000938 502000934 502000945 502000946 502000922 502000958 502000927 502000944 502000942 502000236 502000943 502000941 502000238 502000998 502000250 502000948 502000068 502000294 502000939 502000284 502000212 502000247 502000067 502000966 502000963 502000929 502000903 502000953 502000272 502000937 502000296 502000226 502000260 502000262 502000211 502001050 502001006 502001055 502000935 502000952 502000240 502000206 502000263 502001054 502001073 502001047 502001067 502001008 502000996 502000265 502000969 502000968 502000933 502000279 502000950 502000986 502001002 502000991 502000228 502000254 502000243 502000954 502000999 502001012 502001014 502001052 502001053 502001007 502000993 502000930 502000995 502000947 502000978 502001010 502001017 502001048 502001057 502001011 502001016 502001068 502001049 502001013 502001056 502001001 502000964 502000277 502000255 502000252 502001015 502001058 502001051 502001009 502000274 502000967 502000961 502000904 502000909 502000912 502000905 502000977 502000970 502000233 502000251 502001004 502000298 502000253 502000949 502000203 502000997 502000957 502000989 502000926 502000951 502000291 502000288 502000239 502000931 502000229 502000269 502000210 502000283 502000975 502000901 502000915 502000221 502000983 502000299 502000917 502000923 502000982 502000215 502000202 502000293 502000286 502000258 502000285 502000271 502001003 502000278 502000282 502000213 502000219 502000257 502000962 502000984 502000911 502000292 502000956 502000959 502000921 502000209 502000925 502000900 502000994 502000910 502000918 502000914 502000244 502000207 502000297 502000261 502000928 502000242 502000965 502000266 502000280 502000916 502000241 502000287 502000268 502000273 502000256 502000259 502000913 502000218 502000971
Recalling Firm/
Manufacturer		 Defibtech, LLC
741 Boston Post Rd
Suite 201
Guilford CT 06437-2714
For Additional Information ContactCustomer Service
203-453-6654
Manufacturer Reason
for Recall		Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.
FDA Determined
Cause 2		Process control
ActionOn July 12, 2024, the firm notified affected users via Urgent Medical Device Safety Removal letters. Affected units (as identified by serial number) should be quarantined by the customer. Defibtech will contact customers to arrange for the return of the product. Customers' devices will be refunded, repaired, or replaced at no cost to them. Customers who have further transferred the device to a downstream account must notify those accounts of this notice or provide Defibtech with the contact information for those sub-accounts. Defibtech Customer Support: 1-877-453-4507, 7:30AM - 6PM Eastern, Monday thru Friday.
Quantity in Commerce174 US, 37 OUS
DistributionDomestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to Japan
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DRM
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