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Terminated

Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies

FDA Recall Z-0188-2015 · Posted 2014-12-16

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeKPS
Date Initiated2014-10-14
Date Terminated2015-02-27
Product Quantity29

Reason for Recall

GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.

Firm Action

The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter, GEHC Ref# 40860, dated October 14, 2014 to its consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, actions to be taken and Contact Information. For questions, consignees in the United States, can contact 1-800-437-1171, for other countries they can contact their GE Healthcare Service Representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052434HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERAGE Medical Systems · 2005-09-27K022960GE QUASAR NUCLEAR MEDICINE SYSTEMGe Medical Systems F.I. Haifa · 2002-09-19K991841HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERAGe Medical Systems F.I. Haifa · 1999-08-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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