Impac Medical Systems Inc: Medical Device Recall in 2012 - (Recall #: Z-1944-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086

Product Classification:

Class II

Date Initiated: June 8, 2012

Date Posted: July 18, 2012

Recall Number: Z-1944-2012

Event ID: 62302

Reason for Recall:

Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zero.

Status: Terminated

Product Quantity: 11 affected sites

Code Information:

Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.

Distribution Pattern:

Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated