Device Recall Nuclear Magnetic Resonance Imaging System

Model Number: 2138300-30;  Serial Numbers: 00000203387MR6, 00000208208MR9, 00000216409MR3, 00000229302MR5, 00000229306MR6, 00000230309MR7, 00000231588MR5, 00000237930MR3, 00000239847MR7, 00000241694MR9, 00000247255MR3, 00000253103MR6, 00000189633MR1, 00000192104MR8, 00000193652MR5, 00000194218MR4, 00000194219MR2, 00000194950MR2, 00000196364MR4, 00000197334MR6, 00000198709MR8, 00000199443MR3, 00000201708MR5, 00000201709MR3, 00000201710MR1, 00000201901MR6, 00000202223MR4, 00000203386MR8, 00000204837MR9, 00000204838MR7, 00000204839MR5, 00000206438MR4, 00000206439MR2, 00000207493MR8, 00000207494MR6, 00000208209MR7, 00000208210MR5, 00000209712MR9, 00000209713MR7, 00000212511MR0, 00000212513MR6, 00000212514MR4, 00000212515MR1, 00000215366MR6, 00000216405MR1, 00000216406MR9, 00000216407MR7, 00000216409MR3, 00000217198MR1, 00000217201MR3, 00000221250MR4, 00000221251MR2, 00000221253MR8, 00000221254MR6, 00000222950MR8, 00000225273MR2, 00000225274MR0, 00000225942MR2, 00000226318MR4, 00000228022MR0, 00000228023MR8, 00000228024MR6, 00000228773MR8, 00000229303MR3, 00000229304MR1, 00000229305MR8, 00000230308MR9, 00000230312MR1, 00000231591MR9, 00000231592MR7, 00000232328MR5, 00000233644MR4, 00000233646MR9, 00000234832MR4, 00000234833MR2, 00000234834MR0, 00000237051MR8, 00000237052MR6, 00000237053MR4, 00000237926MR1, 00000237927MR9, 00000237928MR7, 00000237929MR5, 00000239480MR7, 00000239482MR3, 00000239483MR1, 00000239484MR9, 00000239845MR1, 00000239846MR9, 00000241126MR2, 00000241127MR0, 00000241693MR1, 00000241695MR6, 00000243405MR8, 00000244231MR7, 00000244232MR5, 00000247252MR0, 00000247253MR8, 00000247254MR6, 00000247256MR1, 00000250184MR9, 00000250185MR6, 00000250186MR4, 00000250187MR2, 00000253039MR2, 00000253102MR8, Unknown;  Model Number: 2377062-5;  Serial Numbers: 00000000100YR8, 00000000119YR8, 00000000129YR7, 00000000102YR4, 00000000103YR2, 00000000105YR7, 00000000106YR5, 00000000108YR1, 00000000109YR9, 00000000111YR5, 00000000113YR1, 00000000118YR0, 00000000120YR6, 00000000122YR2, 00000000124YR8, 00000000127YR1, 00000000128YR9, 00000000131YR3, 00000000132YR1, 00000000133YR9, 00000000134YR7, 00000000135YR4, 00000000136YR2, 00000000137YR0, 00000000142YR0, 00000000144YR6, 00000000146YR1, 00000000149YR5, 00000000150YR3, 00000000151YR1, 00000000152YR9, 00000000155YR2, 00000943610YM6, 00000951021YM5, 00000962592YM2;  Model Number: 2377062-30  Serial Numbers: 00000003047YR8, 00000003011YR4, 00000003022YR1, 00000003023YR9, 00000003024YR7, 00000003025YR4, 00000003026YR2, 00000003027YR0, 00000003028YR8, 00000003029YR6, 00000003030YR4, 00000003031YR2, 00000003033YR8, 00000003034YR6, 00000003035YR3, 00000003036YR1, 00000003039YR5, 00000003041YR1, 00000003042YR9, 00000003043YR7 and 00000003044YR5.

Radiology Devices

2

No

Worldwide Distribution-- US (including states of AL, ALZ, AR, CA, CO,CT, DE, FL, FA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MT, MO, NE,NH, NV, NJ, NY, NC, OH, OK, OR, PA, PR, SC SD, TN, TX, VA, WA, WV and WI), CHINA, CYPRUS, ARGENTINA, BRAZIL EGYPT, DENMARK, FEDERAL REPUBLIC OF GERMANY, FEDERAL REPUBLIC OF FRANCE, GET 7 D CHINA, GREECE, HUNGARY, ITALY, IVORY COAST, JAPAN, KOREA, KUWAIT, MALAWI, MEXICO, OMAN, PANAMA, PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SPAIN , SWITZERLAND, TURKEY, UKRAINE, UNITED ARAB EMERITUS, UNITED KINGDOM and VENEZUELA.

Signa Openspeed 0.7T MR Systems, Model Numbers: || Openspeed 3 (2138300-30), Openspeed 4 (2377062-5), Openspeed 5 (2377062-5, 2377062-30)