Recall Z-1944-2012— Impac Medical Systems Inc

Name: FDA recall Z-1944-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-08

Class II · Terminated

Class II FDA medical device recall by Impac Medical Systems Inc, initiated 2012-06-08, terminated 2013-06-19. It names one FDA 510(k) clearance: K120067. Product: 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. Reason: 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..

Recalling firm: Impac Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2012-06-08
Terminated: 2013-06-19
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K120067 — MOSAIQ ONCOLOGY INFORMATION SYSTEMImpac Medical Systems, Inc.·cleared 2012-02-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.