Xeleris Processing and Review Workstation 1.0…

Date posted by the FDA

Feb. 15, 2011

Status

Terminated

Filed by

GE Healthcare, LLC

Product

Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0 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. 3X The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing , archiving, printing, reporting and networking of NM data including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomnographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gammna cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration. The NM or PET data can be coupled with registered and/or fused CT or MR scans and with physiological signals, in order to: depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes..

Reason

GE Healthcare has become aware of safety issues relevant for the Xeleris Workstation 1.0, 1.1, 2.0, 2.1, 3.0: 1. Measurements taken on the CT Images on the CT system are different from the Xeleris Workstation 2. Inaccurate PET SUV values may be calculated when data is retrieved from PACS after being processed in the Xeleris. 3. Wrong marking of Early and Late result series on display in Bra

Distribution pattern

Worldwide distribution: USA including DC, PR, and Guam; and countries including: AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA, AZERBAIJAN, BELGIUM, BOSNIA & HERZEGOVIA, BULGARIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KENYA, KUWAIT, LUXEMBOURG, LEBANON, MALY ASIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, PORTUGAL POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SPAIN, SOUTH AFRICA, SOUTH KOREA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, and VIET NAM.

Quantity

6046

Codes and lots

Serial Number 0000CZC5481313 0000FRB43605FW 000000203275-2 0000FRB4330NQ5 0000CZC5361JTH 0000000000UNKN 000000109754-6 0000CZC91280CY 0000CZC8396CD6 0000FRB4190GXV 00000000203292 0000CZC535013W 0000CZC5230HCC 00000108012-14 0000CZC5471LK7 0000CZC7105FJB 0000FRB32609KZ 0000FRB3250CZ3 0000FRB32507GH 0000000L3MMLZX 0000006FD249C7 0000CZC5480KT5 00000FRB3100ZK 0000CZC530033W 0000FRB3270C7R 0000CZC6502HMZ 000000108907 2 0000FRB4370B22 000000207637-1 0000003A2D3897 0000CZC8273ZDX 000000107833-4 0000FRB31602X3 0000FRB4370B48 000000107772-4 0000FRB3270GW4 0000CZC8396CDB 00000109315-10 0000CZC9502HM4 0000FRB4330NNZ 0000CZC724055V 0000CZC548135X 0000CZC5341NX7 0000FRB4370B35 0000FRB4330B4L 000000109291-8 00000108793-19 0000FRB42508WM 0000FRB42508SS 00000000289EL9 0000CZC5341NGK 0000CZC530036R 000000109841-9 0000CZC912751P 0000FRB42508RB 0000FRB44103LZ 0000CZC7205DP8 0000CZC7110GSQ 0000CZC5502N9N 0000CZC7240519 0000FRB42508W2 0000CZC6502HM9 0000CZC9127S8B 0000FRB43705M4 000000286147BC 0000FRB43605GQ 0000FRB40906XP 000000099YGCCT 0000FRB4330B44 0000FRB4330B3R 0000FRB4330BBB 0000FRB4330B7Z 0000FRB4330B3V 0000FRB4330B5Q 0000FRB4330B5C 0000FRB43402XW 0000FRB4210CC7 0000FRB3280C7C 0000FRB43402V8 0000CZC7212F10 00000109460-19 00000CZC8273BM 0000CZC8225781 0000CZC5341P27 0000CZC8273P55 0000FRB3270BG9 0000FRB4330B4G 0000FRB40907L0 00000108976-17 00000108976-48 00000108976-45 00000108976-49 0000FRB4330B3P 0000FRB3260B4Z 000000110436-7 000000212660-7 000000110436-3 000000212660-8 000000212660-1 000000212660-5 00000108118-26 0000CZC6502HJ0 0000CZC7205DPW 00000000107285 0000FRB325098N 0000FRB4370CYS 000000108663-4 000000108663-1 00000000108663 0000FRB3280C71 000000108663-3 0000FRB44103M4 0000FRB44106DN 0000FRB4330NPS 0000CZC8283TYN 000000109983-7 0000CZC6505DQ6 000000205262-3 0000FRB32808BQ 0000CZC8161XJJ 0000FRB3260GYP 000000108597-3 000000108587-2 000000108907 5 0000CZC5481343 00000108012-32 00000000000002 0000CZC5361JQ8 0000FRB4370CZ3 0000CZC7204X6S 0000CZC5471PLP 0000CZC5361JW6 000000206690-0 00000000057340 0000CZC548130M 0000FRB3270C94 0000FRB316014L 0000FRB44103M3 0000FRB44103M3 00000000284EL0 0000KY32061200 00000015418207 0000007438A88D 0000FRB31602Y2 00000032F52A8B 0000CZC552071Z 0000FRB31600YK 000000107912-8 00000108012-16 0000FRB3150L87 0000CZC5341N9H 00000108294-37 00000000057330 0000005DA56D9C 00000000211620 00000CZC8283V4 000000302776A1 0000CZC9127548 000000212425-1 0000FRB3160133 000000204174-7 000000099YGCNC 000000407787B0 0000FRB3250962 0000CZC7105FLM 000000108968-3 0000000L3RX455 0000FRB4380P1Q 0000CZC9127SD7 0000CZC9127SD0 0000CZC7105FCK 00000109541-12 0000CZC530033V 0000CZC8224ZKT 0000CZC8273NS2 0000CZC5341NTB 0000FRB3270C9Z 000KY201801154 0000KY36060429 0000FRB3260GVR 0000CZC5341NJP 000000108298-9 0000FRB42508S2 0000FRB42508VV 00000005597F4B 0000FRB3260H22 0000CZC5230HD3 0000FRB32808C4 0000CZC7110GPZ 000SCZC530034L 000000043025EU 00000000206509 000000206509-4 0000CZC912755G 0000CZC5361JQF 0000CZC530039F 0000FRB3260B11 0000CZC530036P 000000106574-0…

Recall started

Jan. 12, 2011

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 12, 2011 to all consignees/customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to please ensure that all potential users in their facility are made aware of this safety notification and the recommended actions. A GE Healthcare Service representative will perform the required software update on each affected system. If you have any questions or concerns regarding this notification, contact your local GE Healthcare Service Representative. You may also contact GE Healthcare call center in US or Canada at 800-437-1171 and other countries at 262-896-2890.

Recall number

Z-1250-2011

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

Source: FDA · Medical device enforcement report, recall number Z-1250-2011. The agency record governs; check it and the company before acting.