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GE Discovery NM 630 recallZ-1111-2012 · GE Healthcare, LLC · initiated Jan 11, 2012

Terminated All recalls posted in February 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-1111-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 11, 2012
Posted by the FDA
Feb 27, 2012
Recalling firm
GE Healthcare, LLC
Quantity
10
Product code
KPS
FDA submissions
K111445
Distribution
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.

Product description

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.

Code information (models, lots, serial numbers)

22002 22017 22018 22015 22009 22008 22005 22001 22014 22003

Other devices under the same FDA submission

4 devices cleared under K111445 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 60790).

Sources and updates

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