GE Healthcare, LLC: Medical Device Recall in 2013 - (Recall #: Z-1519-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 14, 2013

Date Posted: July 3, 2013

Recall Number: Z-1519-2013

Event ID: 65372

Reason for Recall:

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.

Status: Terminated

Product Quantity: 49 installed in the US.

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated