GE Healthcare Senographe Essential System…

Date

July 3, 2013

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems.

Reason

GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual CD of the Senographe Essential.

Distribution pattern

Nationwide Distribution including the states of NJ, CO, LA, AL, OH, MA, NC, ME, WI, GA, PA, TX, IN, NY, MO, KY, KS, CA, MN, FL and IL.

Quantity

49 installed in the US.

Codes and lots

Models 5144816-10 rev 2, 3 or 6 and 5144816-10-LE rev1.

Recall started

Jan. 14, 2013

Device type

Full Field Digital, System, X-Ray, Mammographic

Root cause (FDA)

Radiation Control for Health and Safety Act

What the company told customers

GE Healthcare will notify customers with affected systems via letter and enclose a new CD- Rom, along with notification that a GE Representative will schedule an appointment to install the User's Manual along with a GE Service Engineer will go on site to install it on the control station of the Senograph Essential system. 16- H LA 6. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter. GE Healthcare will secure and summarize documentation that the manual has been installed and is available on each affected system and provide summarize of the documentation to the district recall coordinator. For further questions please call ( 262 ) 513-4122.

Recall number

Z-1519-2013

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

Source: FDA · Medical device enforcement report, recall number Z-1519-2013. The agency record governs; check it and the company before acting.