Philips Medical Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1044-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Philips Multi Diagnost Eleva II

Product Classification:

Class II

Date Initiated: October 14, 2013

Date Posted: March 4, 2015

Recall Number: Z-1044-2015

Event ID: 69870

Reason for Recall:

The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

Status: Terminated

Product Quantity: 238

Code Information:

Product Code: 708036

Distribution Pattern:

Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated