—#106480

Product

GE Discovery NM 630 The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K111445
Affected lot / code info: 22002 22017 22018 22015 22009 22008 22005 22001 22014 22003

Why it was recalled

GE Healthcare has recently become aware of a potential safety issue associated with the collimator cart and lead cover of your Discovery NM/CT 670 and/or Discovery NM 630 system that may impact operator safety. 1. The cart locking pin release and cart disengagement could result in the collimator falling down and could lead to operator or service personnel injury. 2. Another issue is that the

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated January 13, 2012 to its Consignees/Customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The customers were instructed to continue to use product, ensure that the collimator exchange monitor the collimator cart are properly locked in place; pay attention to any unexpected cart motion during the exchange procedure; cease the process immediately if the cart has moved from the docking spot, dock cart in place again, and complete the exchange; and if a 3rd party service engineer is servicing rather than the firm, GE, advise according to the instructions in letter. A GE Healthcare Service representative will perform the required hardware 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: United States or Canada: 800-437-1171 and Other countries: 262-896-2890.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) including states of: CA, FL, GA, IL, NJ, NY, NC, TX, and WI; and countries of: AUSTRALIA, BELGIUM, CANADA, CHINA, DENMARK, FRANCE, GERMANY, INDIA, ISRAEL, ITALY, KOREA, JAPAN, NETHERLANDS, NORWAY, POLAND, RUSSIAN FEDERATION, SPAIN, SWITZERLAND, UNITED KINGDOM.

Timeline

Recall initiated: 2012-01-11
Posted by FDA: 2012-02-27
Terminated: 2012-12-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106480. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.