Xeleris (1.0…

Date posted by the FDA

Dec. 3, 2010

Status

Terminated

Filed by

GE Healthcare, LLC

Product

XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration.

Reason

GE Healthcare has become aware of inaccurate user protocol setup associated with the Thyroid Uptake Index application on certain Xeleris workstations(1.0, 1.1, 2.0, 2.1) that may impact patient safety. Inaccurate protocol setup by the user while using Thyroid Uptake Index application has been identified on certain Xeleris workstations. Incorrect protocol setup during clinical data acquisition a

Distribution pattern

All States in continental USA including DC and PR. Viet Nam, Venezuela, Uruguay, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Sweden, Spain, South Africa, Slovakia, Singapore, Saudi Arabia, Russian Federation, Republic of Korea, Portugal, Poland, Philippines, Panama, Pakistan, Norway, New Zealand, Netherlands, Morocco, Mexico, Martinique, Malaysia, Luxembourg, Kuwait, Kenya, Japan, Jamaica, Italy, Israel, Ireland, Indonesia, India, Hungary, Hong Kong, Guadeloupe, Greece, Germany, France, Finland, Ecuador, Dominican Republic, Cyprus, Colombia, China, Canada, Bulgaria, Brazil, Bosnia & Herzegovina, Belgium, Azerbaijan, Austria, Australia, Argentina, Algeria.

Quantity

6020

Codes and lots

SN 0000CZC5481313 0000FRB43605FW 0000FRB31602VG 0000FRB31602XV 0000FRB31602TX 000000205262-1 000000205262-2 000000205262-8 00000041E0CFDB 00000033512139 0000000CGMK00J 0000000HBLL50J 00000001P19K0J 00000006GD9K0J 0000FRB31602VS 0000FRB32509B2 00000000040129 0000FRB40906XP 0000FRB4330B3P 0000FRB43605GQ 0000FR31125601 000000099YGCCT 0000FRB4380JXX 0000CZC530038W 000000286147BC 000CZC5484130S 000000696468C0 0000001136348F 000000108796-9 0000000BA60A9F 000000109266-4 00000108976-17 00000108976-48 00000108976-45 00000108976-49 00000109471-23 000000109471-1 000000109460-2 00000CZC8273BM 0000CZC8225781 000000109541-4 000000109935-6 0000FRB40907L0 0000000HYZN70J 00000003T31BOJ 00000003T31B0J 00000003T31BOJ 00000000203325 000000099YGCHW 000000099YGCGK 000000204258-5 0000CZC5230HF2 0000FRB4370B25 000000099HXVXT 0000CZC5341NB2 0000CZC5341NGL 0000CZC5341NLC 00000000207741 000000107859-5 0000FRB4370DGK 00000108968-28 00000050C5965C 00000016BBDA0E 00000109032 18 000000109077-2 00000000210085 000000109408-8 00000109408-19 000000417E8E0E 000000109261-6 000000109624-3 00000046877888 000000109535-4 000000109767-2 00000000005349 00000005597D9P 0000040770-241 0000040770-464 0000FRB32509CJ 0000000GGDCK0J 0000FRB3260GY7 0000FRB3270GH9 0000FRB3250560 0000PA44275203 0000FRB43402X2 00000007GDCK0J 0000FRB3250560 0000FRB3260B7D 0000FRB44109WZ 0000FRB325055R 0000FRB4330B5G 0000PA47015153 0000FRB3270GVR 0000FRB4330B9Z 0000KY33131392 0000FRB4400J0H 0000FRB4330B9K 0000FRB4380C0Q 00000001H2680J 0000000CL2680J 00000000101577 0000000J2LX60J 00000000205819 0000FRB44103KW 0000FRB43708SK 0000FRB4370DGT 0000FRB43708T1 0000FRB43704BL 0000FRB44103KQ 0000FRB44103KC 0000FRB40907J8 0000FRB3270C7W 000000107155-3 0000FRB3260C7H 0000CZC5230HCB 0000CZC5230HCV 0000CZC535012J 0000CZC5310XPX 0000CZC5341NNH 0000CZC5230HCP 0000CZC5341NXM 0000CZC5341NBS 0000003B231900 00000003BB11D0 0000007EDFACA5 00000053972594 0000CZC5341NB6 0000CZC5471CDK 000000108394-5 0000005EAA7B9E 0000004B0DB157 000000738E8044 000000209093-4 0000000AE4672B 00000000108865 0000000328D6BB 00000061F96DE3 000000671D1A93 00000000109515 00000067746E13 0000007B642D27 000000211114-2 000000109283 4 00000109283 13 0000005EE43FCD 0000003FF209C4 000000109754-8 000000268094EE 0000002452179E 000000110137-5 00000000110172 0000006B5FE154 0000CZC91280CY 00000000005110 0000000FCF9K0J 0000000FW1F70J 0000000DQF9K0J 00000008ZZN70J 0000000C23DFOJ 00000002HDCK0J 0000FRB3150L6Q 0000000GSHBK0J 00000005597D6C 000000000-4-15 0000000GCGCKOJ 0000FRB3260B0W 0000FRB32408FY 0000FRB3160120 0000FRB3270GGW 0000040770-078 0000FRB3260GZM 0000FRB3260GY0 0000FRB316013D 0000FRB3280B87 0000FRB316011Z 0000FRB325096K 00000005597F7F 0000FRB3107760 000000099ALYMH 0000FRB32507GV 0000FRB3270GGV 0000FR31125590 000000099YGCFM 0000FRB40907KG 0000FRB32609ZH 000FRB43300BBF 0000FRB3270GVC 000000099YGCGW 000000099YGCKN 0000FRB3250C9L 0000106662-0-0 000000099YGCLH 0000FRB4330B3X 0000FRB44109WW 000000099YGCLK 000000000002HG 0000FRB3280C9S 0000FRB43402W7 0000000FSTKH0J…

Recall started

Oct. 27, 2010

Device type

System, Image Processing, Radiological

Root cause (FDA)

Other

What the company told customers

GE Healthcare sent an "Urgent Medical Device Correction" letter dated October 27, 2010, to all consignees. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology and Radiologists/Cardiologists and Identifed the product, the problem and the action to be taken by the consignees. Consignees were instructed to replace the original protocol instructions provided with their system with the updated protocol instructions provided with the letter. For any questions consignees were to contact their local GE Healthcare Service Representative or contact the GE Healthcare Call Center: United States or Canada (800) 437-1171 Other countries: (262) 896-2890

Recall number

Z-0537-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0537-2011. The agency record governs; check it and the company before acting.